SAHLGRENSKA ACADEMY
SAHLGRENSKA SCHOOL OF
INNOVATION AND
ENTREPRENEURSHIP
UNDERSTAND THE PROCESS, INFLUENCE
THE OUTCOME
- A study on processes and decision making in
selection of industry clinical trials locations
Linnea Eidrup Dahlberg
Sahlgrenska School of Innovation and Entrepreneurship
Essay/Thesis:
Program and/or course:
Level:
Semester/year:
Supervisor:
Examiner:
Report:
30 hp
Business creation and Entrepreneurship in Biomedicine
Second Cycle
Spring 2016
Håkan Billig
Boo Edgar
1
Abstract
Essay/Thesis:
Program and/or course:
Level:
Semester/year:
Supervisor:
Examiner:
Report No:
Keyword:
Purpose:
Theory:
Method:
Result:
30 hp
Business creation and Entrepreneurship in Biomedicine
Second Cycle
Spring 2016
Håkan Billig
Boo Edgar
4
Clinical trials, decision making, trial location, industry clinical
trials, pharmaceutical development, communication, marketing,
Clinical Studies Sweden
The primary objective is to define what characterises the decision making
process when a clinical trials sponsor and/or performer makes a choice where
to locate a new trial. Secondly, to identify on what arenas a clinical trials
sponsor and/or performer encounter information. The goal is to be able to use
the information to influence the decision and communicate the Swedish system
for clinical trials most efficiently. The intention is to build a knowledge base
that supports the Office for Clinical Studies, Swedish Research Council in
achieving its strategic goal of a marketing that increases the interest of
conducting clinical trials in Sweden.
Generally, the literature agrees on certain high level factors as being the main
drivers behind clinical trials location choice. Although, it is evident these
factors are consisting of several sub-categories. Here, previous literature points
in different directions as to what the central factors are. New forms of business
models and changes in what types of trials are being conducted has changed
the landscape for pharmaceutical development. Further, both traditional and
new channels for information sharing are being utilized when deciding upon
trial location.
A combination of qualitative and quantitative methods was used. In depth,
face-to-face interviews with relevant stakeholders is the primary data
collection method, while a web based survey aims to support the results
generated during interviews.
The result provides suggestions on how external input can be strategically
formulated, to positively influence companies’ choice of trial location, based
on their need and objectives in the various stages of the process. By
understanding this can external actor’s such as the Office for Clinical Studies,
Swedish Research Council get support in their ability to give clinical trials
sponsors/performers the right information at the right stage.
Foreword
This thesis is a result of the work conducted by Linnea Eidrup Dahlberg during the Spring
2016 of the Master’s Program in Business Creation and Entrepreneurship in Biomedicine at
the Sahlgrenska School of Innovation and Entrepreneurship at the University of Gothenburg,
Sweden.
I have been incredibly privileged to have been able to be part of the Office for Clinical
Studies, Swedish Research Council during this spring. I would like to thank Kaj Stenlöf and
the staff at the Office for Clinical Studies for generously welcoming me and for their
contributions to this thesis.
I would like to give a special thanks, and express my gratitude to my mentor Håkan Billig for
his support and advice in this process.
Additionally, I would also like to thank everyone who has made a contribution to this thesis
and who agreed to be interviewed, providing me with valuable insights and recommendations.
Linnea Eidrup Dahlberg
Gothenburg, June 14th 2016.
1
1.Introduction .............................................................................................................................. 3
2. Background .............................................................................................................................. 3
2.1 Problem Formulation ..................................................................................................................... 3
2.2 Is there a need to reverse the trend? ............................................................................................. 5
2.3 Aim ................................................................................................................................................. 6
2.4 Data interpretation and Concept building ..................................................................................... 7
2.5 Delimitations .................................................................................................................................. 8
3.Main Question and research questions ...................................................................................... 9
3.1 Main question ................................................................................................................................ 9
3.2 Research Questions ........................................................................................................................ 9
4. Methodology ............................................................................................................................ 9
4.1 Methodological Approach ............................................................................................................. 9
4.2 Qualitative data collection ........................................................................................................... 11
4.3 Quantitative data collection ........................................................................................................ 14
5. Theoretical Framework ........................................................................................................... 16
5.1 Determining factors for clinical trials location............................................................................. 16
Prevalence of study disease and proven success .......................................................................... 16
Access to patients and time ........................................................................................................... 18
External environment .................................................................................................................... 20
Important factors in relation to Sweden........................................................................................ 22
5.2 The Pharmaceutical Development Landscape ............................................................................. 25
A Changing Landscape.................................................................................................................... 25
5.3 External channels for information ............................................................................................... 27
5.4 Patient recruitment ...................................................................................................................... 27
5.5 Channels for knowledge and information sharing....................................................................... 30
Initiatives to attract clinical business ............................................................................................. 30
Social media as a channel for information and knowledge sharing .............................................. 31
Networks and Partnerships ............................................................................................................ 33
5.6 Decision making ........................................................................................................................... 35
6. Result ..................................................................................................................................... 37
6.1 Qualitative Research .................................................................................................................... 37
Decision making ............................................................................................................................. 40
External channels for information ................................................................................................. 42
Challenges ...................................................................................................................................... 43
6.2 Quantitative Research ................................................................................................................. 49
7. Conclusion .............................................................................................................................. 54
Stage 1. Important Factors, Needs & Objectives ........................................................................... 54
Stage 2. Information Gathering...................................................................................................... 56
Stage 3. Decision making process .................................................................................................. 58
Stage 4. Trial Start .......................................................................................................................... 59
Impact opportunities ..................................................................................................................... 60
Stage 1 ............................................................................................................................................ 61
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Stage 2- 3........................................................................................................................................ 65
Stage 4 ............................................................................................................................................ 66
8.Reflections .............................................................................................................................. 67
Reflection on method .................................................................................................................... 67
Reflections on results ..................................................................................................................... 68
9. References ............................................................................................................................. 70
Appendix 1. Framework of questions .......................................................................................... 75
Introduction- Aim of study ............................................................................................................. 75
Background information ................................................................................................................ 75
Country selection strategies .......................................................................................................... 75
Decision making process ................................................................................................................ 75
Information channels ..................................................................................................................... 76
Other .............................................................................................................................................. 77
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1.Introduction
As of autumn 2014, a national initiative to jointly support and develop the conditions for
clinical studies1 in Sweden was introduced. This governmental initiative, Clinical Studies
Sweden is a collaboration between the Swedish Research Council and Sweden's Health Care
regions. The system is led by the Committee for Clinical Studies, consist of six regional nodes
and the Office for Clinical Studies, Swedish Research Council. The vision is to build a strong
national infrastructure for clinical studies of high quality that provides the best possible
conditions for the development of health care. Several projects have been initiated to support
this process, for example simplification of administrative routines, overview of legislations
and regulations as well as development of a web-based information platform for patient
recruitment.
2. Background
2.1 Problem Formulation
Although there is no standardised method to measure and compare definite numbers of
clinical trials2, a downwards trend in number of clinical trials can be seen in several countries,
particularly in Europe and the Nordic countries (Ås Sivborg, S, 2014; Tillväxtanalys 2014).
Sweden in particular seems to have had a steeper downhill curve, and it has been argued that
the country has lost a previously strong position within the field (Ås Sivborg, S, 2014). It can
be clearly stated that few of the major pharmaceutical companies in the world has Sweden as
one of its primary choice of countries for location of their clinical trials (Petersson, I. 2013).
The main reasons for this trend are the increased pressure on pharmaceutical companies to be
cost effective, as well as larger competition from growing economies such as China and East
Europe (Pettersson 2013). Competition among companies and drugs going off patent has
made many companies shift their focus. One industry trend is that companies to a larger
extent cooperate with the academia and health care to more thoroughly understand disease
mechanisms (Petersson 2013). Consequently, this has resulted in companies decreasing their
internal early stage R&D. Potential drug candidates are now being bought from academia or
smaller companies and taken into later stage research. In other words, many pharmaceutical
companies have shifted their focus to later stages of drug development where large recourse
demanding trials are required (Petersson 2013; Vasco Advisers 2014).
Actions have been taken on national-, international- and EU-levels in order to increase the
assigning of clinical trials to Europe. National initiatives can be seen in several countries
1
“A clinical study is a research study using human subjects to evaluate biomedical or health-related outcomes.
Two types of clinical studies are interventional studies (or clinical trials) and observational studies” (Glossary of
Common Site Terms - ClinicalTrials.gov. 2016). Clinicaltrials.gov).
“A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so
that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The
assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other
types of interventions” (Glossary of Common Site Terms - ClinicalTrials.gov. 2016).
3
2
similar to Sweden. For instance, Denmark, Belgium and the United Kingdom have made
significant investments with the intention of attracting more clinical trials to their respective
country. The initiatives taken by these countries have resulted in major domestic system
changes (Ås Sivborg, S, 2014). Initiatives on an international level can be seen in the Nordic
Countries. For instance, The Nordic Trial Alliance is a collaboration that aims to increase the
number of clinical trials in the entire Nordic region (Nordic Trial Alliance 2016). On a
governmental level, initiatives have been taken by the EU. The EU Clinical Trials Directive
2001/20/EC intends to facilitate for trials on a transnational level by streamlining the
application process (Clinical trials -Directive 2001/20/EC - European Commission", 2016).
Approximately 4000 requests to perform clinical trials are each year managed by the EU - of
which about 24% aims to be conducted in at least two EU countries. By co-ordinating
requirements on national levels, the EU aims to reduce inefficient use of resources and
prolonged application processes by 2017/2018 (Nordin 2015). However, the new directive
also creates new demands on each country, especially for those with specific national
requirements. The Swedish law on Bio banks is one example of this. According to this law, a
specific agreement must be made dependent on the client and the request, and this will create
hurdles for Sweden´s ability to adapt to the new EU directive (Jensen, S. 2016).
Despite the many efforts to attract more clinical trials to Europe, a need to identify the key
drivers of decision making preceding the placement of a clinical trial can still be seen.
According to Gehring, et al. (2013), an uncertainty still exists in “which specific
recommendations should be implemented or prioritized at either national or Pan-European
level”. The authors claim this is due to insufficient understanding of the driving forces behind
a decision to locate a study to a European site.
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2.2 Is there a need to reverse the trend?
It is essential for countries to strengthen their respective positions on the clinical trials field.
Trials are important for several reasons. Not only do patients get access to therapies in the
forefront of research, they also get access to therapies that are not yet available on the market
(Maes, 2012). Conducting research within the healthcare and close to the patients also
increases the quality of care and contributes to increased knowledge. This knowledge
gathering is essential for the development of care and the implementation of new therapies
(IVA 2014), (Tillväxtanalys 2014). Moreover, Sweden is a knowledge driven economy that
needs to continuously develop and increase the knowledge base. Implementing new
information is fundamental for the country’s future development (Tillväxtanalys 2014).
The increased pressure on Swedish healthcare has gradually shifted the focus from
administrating clinical trials towards healthcare production and solving the problems of the
day. This has had negative consequences on industry sponsored trials, while academia and
healthcare-initiated studies have not seen the same downward trend. The implication of this is
that the climate and conditions for industry clinical trials is Sweden is lacking behind (IVA
2014).
Clinical trials are essential for the Swedish Life Science industry as it increases the
attractiveness and contributes to strengthen Sweden’s position on the international arena both by being in the forefront of research and in business (IVA 2014), (Tillväxtanalys 2014).
In 2015 the members of LIF, the trade association for the research-based pharmaceutical
industry in Sweden invested 5,4 billion SEK in clinical research in the country
(Läkemedelsindustriföreningen, 2015). Giving us an understanding of the significance and
impact of this industry sector. Increasing the number of clinical trials in Sweden will support
an expansion in R&D spending by the industry as well as contribute to development of
scientific knowledge and capabilities (The Boston Consulting Group, 2015). Not being an
active part in studies will have consequences for both patients and health care. Directly does
this mean that if Swedish clinics does not take part in studies, patients do not get fast access to
new drugs and therapies. In a longer perspective could this result in the Swedish Health Care
lacking behind internationally and Sweden as country will also not be considered as an
applicable trial country for future research in medicine (Jensen, S, 2016).
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2.3 Aim
To reverse the negative trend in number of performed clinical studies in Sweden, queries
around what needs to be changed and built nationally in terms of infrastructure and incentives
are essential. These questions have to a large extent been discussed in previous literature
(IVA 2014; Petersson 2013; Vasco Advisers 2014). This has led up to several initiatives, of
which many falls under the Office for Clinical Studies, Swedish Research Council´s
undertaking to jointly support and develop the conditions for clinical studies in Sweden.
Building an attractive clinical trials environment and a supporting infrastructure is one step
towards strengthen Sweden’s position in this field. But it is equally important that those who
conducts, pays and performs studies considers Sweden a viable option (Gehring, et al. 2013).
One part in achieving this is to be able to communicate the Swedish system in the right way
and on the right arenas. As in any marketing, this evolves around the importance of presenting
an offer that matches the customer needs and objectives and to package and communicate that
offer it in the most effective way.
The primary objective of this study is to define what characterises the decision making
process when a clinical trials sponsor and/or performer makes a choice where to locate a new
study. Secondly, to identify on what arenas a clinical trials sponsors and/or performer
encounter information on possible trials sites. The goal is to be able to use this information to
influence the decision making process and communicate the Swedish system for clinical trials
most efficiently. This thesis aims to support the Office for Clinical Studies, Swedish Research
Council in achieving its strategic goal of a marketing which increases the interest of
conducting clinical trials in Sweden.
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2.4 Data interpretation and Concept building
The data collected will be used to identify potential “dos” and “don’ts”, as well as good
methodologies to build an argumentation for how one can have an impact on the decision
making process surrounding selection of clinical trials sites.
The aim is to use the insights and lessons learned to construct proposals for what should be
communicated, as well as how and where Sweden should be promoted as an attractive
country for performing quality clinical trials. The intention is to build a knowledge base that
supports the Office for Clinical Studies, Swedish Research Council in achieving the goal of
constructing a marketing strategy that increases the interest of performing clinical trials in
Sweden.
To support the result of this study, a model has been constructed, presented in Figure 1 below.
The model aims to give a high-level view of the process, from companies’ internal strategy
generation to factual clinical trial start. Clearly the model is a simplification of reality, but as
it is constructed to accomplish a general understanding of the industry´s objectives and
decision-making process, it still fulfils its purpose. It aims to support the Office for Clinical
Studies, Swedish Research Council in their pursuit to have positive impact on all categories of
industry trial performers in order to attract clinical trials of all types and phases. The intention
is to visualize in what stages one could have impact on the process, based on the need and
objectives in the various stages.
Figure 1. Process of clinical trials location choice
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2.5 Delimitations
This study´s focus is to look into the area of industry interventional studies or clinical trials.
This limitation is due to the fact that pharmaceutical companies together with Clinical
Research Organisations conducts the main part of studies in Sweden (Pwc, 2013). Moreover,
publicly or investigator initiated clinical trials that are taking place within the health care or
academia have different needs and objectives compared to industry clinical trials. Likewise
does the economic and administrative resources vary between these segments, which makes
generalization very difficult (Eriksen & Kierulf, 2010).
Medical technology products are not required to undergo clinical trials on the same basis as
pharmaceutical product. A clinical trial for a medical technology product is only required if
the information about the performance, safety, and clinical benefits of the product can’t be
verified by any other means (Medicintekniska produkter – Läkemedelsverket, 2016). Instead
a so called Health Technology Assessments (HTA) is made for medical technology products.
The HTA analysis evaluates the product from a health economic perspective, from an
organizational point of view, and from an ethical standpoint. The evaluation is based on an
overview of the scientific literature published on the subject. The strength of the evidence is
assessed on a scale 1-4, where 1 stands for Insufficient scientific evidence and 4 stands for
Strong scientific evidence (HTA-centrum, 2016). Further, medical technology products are
merely required to have a CE-mark. The CE-mark is a verification from the producer that the
product upholds the requirements set by the Medical Product Agency (Läkemedelsverket).
These requirements vary dependent on type of product and its bodily invasiveness, products
are divided into six different categories, dependent on their use and risks. ("Vägen till CEmärket - Läkemedelsverket", 2016).
Due to the above mentioned factors, an assumption that processes and timelines for medical
technology companies greatly differ from pharmaceutical companies and other entities
performing industry clinical trials was made. It can further be assumed that the incentives for
medical technology companies differ from what motivates pharmaceutical companies.
Therefore, has the author chosen to not include medical technology companies in the study.
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3.Main Question and research questions
3.1 Main question
By understanding the industry´s objectives and decision-making processes, can we understand
how Clinical Studies Sweden should be communicated in order to have a positive impact on
industry trial performers in order to attract trials?
3.2 Research Questions
Research Question 1- How can a common country selection strategy used by industry
clinical trials sponsors and/or performers be described, what are their needs and objectives?
Research Question 2- What characterises the internal decision making process when a
clinical trials sponsor and/or performer selects where to locate a study?
Research Question 3- By what external channels does a clinical trials sponsor and/or
performer encounter information on possible locations to perform a study?
Research Question 4- How can we use this knowledge to effectively package and
communicate the Swedish clinical trials system towards industry clinical trial actors?
4. Methodology
In this part, the methodology will be presented. Specifically, the study design will be
motivated and described. This part will also describe how the data was collected, present the
interviewees, and clarify how the analysis was conducted.
4.1 Methodological Approach
To get a comprehensive picture of current information and the existing knowledge gaps, a
brief literature overview and background research was made, which partly included reports
and material compiled by the Office for Clinical Studies. Following the primary literature
study, research questions was developed in cooperation with the thesis supervisor. Followed
by a second, systematic literature study.
This thesis seeks to get a deeper understanding of the pharmaceutical industry´s need,
objectives, and decision-making processes for clinical trial location choice, case studies was
choses as the primary research method. Given the nature of this thesis, and the limited time to
conduct the study, a combination of qualitative and quantitative methods was used. According
to Yin (2009), case studies can include quantitative evidence to support the gathered
qualitative data (Yin, 2009). In depth, face-to-face interviews with relevant stakeholders is the
primary data collection method, while a web based survey aims to support the results
generated during interviews. Moreover, the combination of qualitative and quantitative
methods aims to gain as much and as reliable data as possible given the time and recourses
available. The quantitative method aims to support the primary qualitative method in this
9
regard. As qualitative research offers certain flexibility, as social research does entail a
component of uncertainty and unknown factors, which the researcher has to be able to relate
to (Ritchie & Lewis, 2003).
As mentioned above, the study was initiated by a literature overview which partly included
reports and material compiled by the Office for Clinical Studies and the primary literature
review followed. Consultation with experts in the field was also made to get a comprehensive
picture of the current state of knowledge within the area. As the research area is closely
connected to the business context, the author choose to not strictly include academically
published literature, but also studies and reports made by other entities. It needs to be taken
into consideration that using non-academic sources may create limitations for the translation
into results and should be interpreted with care and all non-academic recourses are evaluated
by the author in this aspect. Nevertheless, did the author choose to include some nonacademic sources as they may bring a deeper understanding of the business context in relation
to the main question.
The sampling for data collection was made by contacting individuals known to the author or
to the Office for Clinical Studies and further sampling was made via those individuals or by
contacting supplementary companies within the field. Using sources know to the Office for
Clinical Studies beforehand may bring an element of partiality to the answers given. But was
deemed by the author as an effective way to get access to key sources of information. To
mitigate the risk of partiality, the author informed the interviewees that the study primarily
was made as an independent research project and stands alone in relation to the Office for
Clinical Studies, Swedish Research Council. Although, the Office for Clinical Studies has the
possibility to make use of the results.
At a later stage an additional interview was conducted, in relation to the challenges brought
up by respondents during interviews. The interview was made as a consultation to get a
deeper understanding of how these challenges has been comprehended on a governmental
basis and how they are being undertaken.
From an ethical standpoint it is important to recognise the fact that the study is made with a
business context in mind and therefore is it industry actors´ views that are reflected in the
result. Hence, opinions of other actors and stakeholders in the clinical trials field, such as the
health care and patients are primarily not included, nor reflected upon.
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4.2 Qualitative data collection
In the following section the different stages and processes used for the qualitative data
collection and analysis is presented.
A semi-structured framework of questions was used as a basis for interviews. This allowed
for in-depth answers without having to interrupt the responders (Eriksson and Kovalainen,
2013). An interview questionnaire was developed as a result of the literature study, which
identified the most relevant issues within the research area. The relevance of the questions
and the framework was evaluated by an individual well familiarized with the clinical trials
environment and its processes. The structure of the questions was based on the order of the
research questions, which aims to answer the main question in a systematized way. The
questionnaire was made with open-ended questions, with the intention to let the interviewee
reason around the questions and express their personal opinions about the topics. The thesis
aims to cover several aspects of the pharmaceutical development value chain. To gain a
comprehensive picture and a representative sample, interviewees was selected from both large
pharmaceutical companies, Small/medium sized pharmaceutical companies, Clinical
Research Organizations as well as an investment firm for pharmaceutical projects and startups. Medical technology companies were excluded from the sampling, due to the reasons
mentioned under “delimitations” above.
Individuals with relevant insight into the field, known to the author or to the Office for
Clinical Studies were contacted at the initial stage. Further sampling was made via those
individuals or by contacting supplementary companies within the field. The inclusion
criteria’s entailed:
-
Insight and understanding of the clinical development and the clinical trials processes
Working with or in close relation to the company’s decision making on clinical trials
location
- Management position preferred
- An understanding of the Swedish context as well as an international perspective.
Exclusion criteria’s entailed:
- Not having sufficient knowledge of the clinical trials processes (Medical affairs and
Clinical operation managers was thus preferred over Human recourses and Sales
representatives)
- Individuals working within medical technology
The data collection was primarily made by sit down, face-to-face interviews with the subjects,
presented in Table 1 below. On three occasions was meeting in person not achievable and the
interview was instead conducted via telephone.
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The analysis was conducted using Ritchie and Lewis´s (2003) concept of “analytic
hierarchy” (Ritchie & Lewis, 2003). The analytic hierarchy is based on several steps so called
”viewing platforms” which supports the process towards gaining a comprehensive overview
and make sense of the data gathered. The process is iterative and allows for building of new
concepts and revaluation of the data as the analysis moves along. Ritchie and Lewis (2003)
states “movement between the data and the analytic concepts, repeatedly going backwards
and forwards, will help to produce greater refinement in the analytic account developed. The
ability to move up and down the analytical hierarchy, thinking conceptually, linking and
nesting concepts in terms of their level of generality, lies at the heart of good qualitative
analysis” (Ritchie & Lewis, 2003).
Firstly, to manage the data, the gathered raw data was transcribed to be able to stay as close to
the original data as possible. In two cases the interview was not possible to transcribe as the
interviewee did not consent to recording, instead interview notes was used. To sort and reduce
the data a set of themes and concepts were created, based on reoccurring themes, ideas and
opinions brought up by the interviewees. The data was labelled under these concepts. The
labelling process was carried out manually, using colour-coding and indexing. Concepts and
themes derived from the data was titled as closely as possible to the terms and language used
by the interviewees. Secondly, to make sense of the data, it was sorted into three segments,
dependent on company type. This to able distinction between segments, to capture different
perspectives and meanings dependent on the segment. As specific patterns were detected the
different concepts was refined and further developed to mirror the result and make sense of
the same.
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TITLE
COMPANY
LABEL
Head Pharmaceutical
Development and
Quality
CEO
Small or Medium sized
Entity in Pharmaceutical
Head Pharmaceutical Development
and Quality, SME Pharma
Small or Medium sized
Entity in Pharmaceutical
Small or Medium sized
Entity in Pharmaceutical
Small or Medium sized
Entity in Pharmaceutical
Large Pharmaceutical
company
Large Pharmaceutical
company
CEO, SME Pharma
Large Pharmaceutical
company
Large Pharmaceutical
company
Clinical Research
Organization
Clinical Research
Organization
Medical Director, Large Pharma
Medical Affairs
Director
CEO
Research Director
Global Clinical
Operations Country
Manager
Medical Director
Clinical Project leader
Clinical research
manager
Project Manager, Late
Phase
Medical Affairs Director, SME
Pharma
CEO, SME Pharma
Research Director, Large Pharma
Global Clinical Operations Country
Manager, Large Pharma
Clinical Project leader, Large Pharma
Clinical research manager, CRO
Project Manager, CRO
Table 1. List of interviewees entailing Title, Segment and Label
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4.3 Quantitative data collection
The second part of the data collection was made via a web-based survey. The survey was
created using the design tool SurveyMonkey (SurveyMonkey Inc., 1999). The structure was,
as for the qualitative questionnaire framework, based on the order of the research questions,
aiming to answer the main question in a systematized way. The survey consisted of a total of
of nine questions and was estimated to take less than ten minutes to complete. The survey was
divided into four parts.
1. Background information. Basic information about the informant, intending to facilitate
the data analysis and distinguish differences in opinion based on organization type,
department and/or clinical phase where the respondent is currently operating.
2. Country selection strategies. Aiming to define how a common country selection
strategy used by industry clinical trials sponsors and/or performers can be described.
3. Decision making process. Aspiring to understand what characterises the internal
decision making process when a clinical trials sponsor and/or performer selects where
to locate a study.
4. Information channels. Aimed to identify by what external channels a clinical trials
sponsor and/or performer encounter information on possible locations to perform a
study.
The survey design and the formulation of questions was reviewed by one individual currently
working with strategic marketing of Sweden, by two individuals with experience of
pharmaceutical marketing as well as by two individuals currently working within
pharmaceutical development (clinical trials phase II respectively phase III).
Selection of target population was made by non-probability sampling (Statistics Sweden,
Research and Development, 2008). Similar to selection of respondents for interviews,
individuals with relevant insight into the field, known to the author or to the Office for
Clinical Studies was initially contacted with a request to participate in the survey. Further
sampling was made via those individuals or by contacting supplementary companies within
the field. All correspondence was made via email, each participants was informed of the
intention and goal of the study as well as the supportive function of the Office for Clinical
Studies, Swedish Research Council. A schedule with contact information, date of first contact
as well as response rate was generated.
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Inclusion criteria’s entailed:
-
Insight and understanding of the clinical development and the clinical trials processes
Working with or in close relation to the company’s decision making on clinical trials
location
- Management position preferred
- An understanding of the Swedish context as well as an international perspective.
Exclusion criteria’s entailed:
- Not having sufficient knowledge of the clinical trials processes (Medical affairs and
Clinical operation managers was thus preferred over Human recourses and Sales
representatives)
- Individuals working within medical technology
- Previously partaken in the qualitative data collection.
The target population included individuals from both large Pharmaceutical companies,
Small/Medium sized pharmaceutical companies and Clinical Research Organizations.
Medical technology companies were excluded from the sampling, due to the reasons
mentioned under “delimitations” above.
Lastly, the quantitative and qualitative data sources were compared and set in relation to each
other and in relation to the theoretical framework to create explanations and enable
conclusions. The conclusions made are grounded on the patterns in the data and by presenting
the explanations given by the respondents.
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5. Theoretical Framework
In this part, previous research and studies made on the pharmaceutical industry´s objectives
and decision making process in relation to clinical trials location choice will be reviewed and
presented.
5.1 Determining factors for clinical
trials location
Generally, the literature agrees on certain high
level factors as being the main drivers behind
clinical trials location choice on a country level. The main factors can be summarized as time,
cost, regulatory conditions, expertise (quality) and patient access (Bailey et al. 2006), (Maes,
2012), (Petersson, 2013), (Myndigheten för tillväxtpolitiska utvärderingar och analyser,
2014). Although, when studied more thoroughly it is evident these factors are consisting of
several sub-categories. Here, previous literature and studies points in different directions as to
what the central factors are.
Prevalence of study disease and proven success
In 2013, the result of a quantitative survey by Gehring, et al. (2013) was published in The
British Medical Journal. The survey reached over 480 respondents from 34 different
countries. Respondents came from several segments within the pharmaceutical industry, both
large and small/medium enterprises (SMEs), medical technology companies and Clinical
Research Organisations (CROs) and Clinical Trials Units (CTUs) was represented in the
study. The aim of the study was to find and describe the main factors influencing clinical trial
site selection in Europe. The impact and significance of the so called SAT-EU study, is
supported by the fact that the majority of survey participators described themselves as “being
directly involved in trial site selection decisions” (Gehring, et al. 2013) almost two-thirds of
respondents either personally supervised or sat on the selection committee of trial sites of
their respectively organisation (Gehring, et al. 2013).
The key criteria’s believed to have an impact on site selection was categorized under four
sub-groups, as presented in Table 2 below.
16
GROUP
CRITERIA’S
Environmental
dependent
factors
Eligible patients in region/size of market; Speed of approvals; Speed of
Ethics Committee; Perceived “trial friendliness”; Government
financial/tax incentives; Cost of running trials; Disease management
system/i.e. nr of specialized referral hospitals; Disease management
networks.
Hospital/Unit
dependent
factors
Site personnel study experience and training; Site personnel language
capabilities; Facilities required by trial (e.g. labs); Availability of trial
specific equipment (e.g. imaging); Hospital QA process; Hospital
institutional approval system.
Investigator
dependent
factors
Investigator interest; Previous experience in similar studies; Concurrent
trial workload; Recruitment and retention track record in prior trials;
Publication track record
Cost dependent
factors
On relevant markets, (investigated both separately and as part of the
environmental category)
Table 2. List of key criteria’s believed to have impact on site selection. Adapted from Gehring, et al. 2013.
Based on the survey result, the relevance of the four groups was weighted against each other.
The factors within each sub-category was likewise weighted in relation to one another. The
outcome of the study showed some unexpected results. Cost is often claimed to be one of the
main factors influencing country selection, and frequently used as and explanation to why
Europe has had a decline in number of trials (Petersson, 2013), (Ås Sivborg, S, 2014).
However, according to the study in The British Medical Journal the relative influence of cost
factors is poorly understood and the results revealed that costs connected to the execution of a
trial as well as governmental incentives (such as tax breaks) are “not the main consideration
when selecting European sites” (Gehring, et al. Factors influencing clinical trial site selection
in Europe: The Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study) BMJ
open 2013). Although, as the study does not explore the particular cost items deeper and, as
also pointed out, a deeper understanding of the impact of direct versus indirect costs, such as
the administrative burden, is needed. The study does argue that governmental incentives
connected to costs, such as tax cuts are seen by the survey participants as having less impact
than factors such as speed of approval, eligible patients and other factors connected to the
surrounding environment (Gehring, et al. 2013).
17
Additional to shredding light upon the questionings of costs, the main findings of the study
indicated essential investigator related factors. The most vital were the investigators merits
form previous trials, personal experience and own interest. Regarding the environmental
factors, the market size and prevalence as well as time to approval and the accesses to
networks for disease management were shown to be most essential. Further, according to the
respondents, the most important hospital- driven criteria’s were own previous familiarity with
a particular site along with education and experience of staff as well as access to the facilities
and equipment required for the particular trial (Gehring, et al. 2013).
According to a white paper published by Premier Research (2014), seen from a high
perspective, three things forms the centre of the strategy, on which companies base their
country selection. Primarily, determining prevalence of the study disease in different
geographic areas. Secondly, identify those countries where a high prevalence of potential
participants corresponds with concrete access to the same group. Lastly, companies select
countries with proven success in patient recruitment and are merited in providing reliable and
high quality data (Premier Research 2014). Although the white paper by Premiere Research
mainly discuss rare diseases and paediatric studies, therefore may the strategies mentioned
above not apply to all varieties of clinical trials.
Access to patients and time
Belgium is in many ways a comparable country to Sweden. A country with a small
populations size and a strive towards strengthen a traditionally strong position within Life
science and clinical trials (Maes, 2012). A Belgian initiative to secure and strengthen the
country’s position in the field of clinical trials, was launched in 2010. As a part of the Belgian
initiative to strengthen the country, an analysis was made by Pwc during 2011-2012. One part
of the analysis was to investigate “how decisions on where clinical trials will be conducted
are made and by whom” (Maes, Clinical Research Footprint and Strategic Plan to Promote
Clinical Trials in Belgium, Pwc, 2012). The study aimed to find what drives decision on
location and identify the key motives and limitations for choosing Belgium as trial country,
and further set in relation to other countries in Europe. The research established a strategic
plan how to encourage clinical trials in Belgium and it is also the underlying basis for how
Belgium will strengthen its position in the field and subsequently attract additional industry
clinical trials (Maes, 2012).
Belgium does still hold a leadership position in relation to population size, with the most
participants in trials per capita. Reasons for this is Belgium´s strong networks of researchers,
research centres as well as a strong presence of pharmaceutical companies in the country. To
the largest part, clinical trials in Belgium are industry sponsored. According to the report
made by Pwc, industry trials are also the type of trials that makes for the highest investments
rates and the most employment possibilities for a country (Maes, 2012). This picture is
corresponding with the development in Sweden, where industry financed trials has had a
stronger decline compared to other types of trials (IVA 2014), (Tillväxtanalys, 2014).
18
In the Belgian study, questions on drivers of decision related to choice of location and the
processes behind a decision was asked to 53 stake holders and decision makers within the
clinical trials area. On a higher level, did the result correspond with previous literature. Time
was the single most important factor among the drivers highlighted as essential for choosing
Belgium as trial country. This included all aspects of approval timeline, time to initiate and
set up of study, time dedicated to recruitment of patients as well as time to first patient visit
(Maes, 2012). That time is considered the most decisive factor corresponds to the
pharmaceutical industry´s increased need and effort to manage a heighten pressure on
development and increased R&D costs (IVA, 2014).
A specific factor underlined in the Belgian report was access to patients. Belgium has, similar
to Sweden, limited conditions regarding patient population size and “treatment-naïve”
patients, which implies patient with no previous treatment for their condition. Although these
conditions are an important part, key decision drivers were considered to be with what ease
one would get access to patients by means such as specific tools/processes for recruitment or
via patient organisations (Maes, 2012). On the other hand, what came forward in the Belgian
study was that a location´s market potential, in this particular study measured as potential
return on investment through targeted population available, how easy one gets market
approval and access to reimbursements was not one of the key drivers of decision in relation
to other factors compared (Maes, 2012).
Furthermore, location choice seemed to be based to a large part on ability to provide quality
and expertise. This included both site specific factors such as the expertise of the site
personnel, the quality in performance of a trial and adherence to GCP3 guidelines. As well as
expertise on a general level such as the competences of authorities and ethics committees
(Maes, 2012). According to the Belgian study, pharmaceutical companies put more value on
the ability to predict the outcome of a trial. Additionally, the efficiency and transparency of
the trial and trial site processes are of significance for a company’s selection choice. This
includes transparency and standardisation of trial costs and efficiency in negotiation of
contracts (Maes, 2012). These factors do all relate to the pharmaceuticals industry’s need to
be increasingly cost effective and shorten time to market.
There are many factors to be considered when selecting site and each clinical trial provides
distinctive challenges and conditions. For a successful trial, a sponsor needs to use as much
available information as possible to be able to identify the most suitable country and sites to
carry trough the study. The challenge lies in identifying the most optimal setting for each
specific study (Harper, B. D., & Zuckerman, D. 2006). Companies spend time and recourses
on identifying the best study location and investigators. Despite these efforts, many trials fail
3
“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this
standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent
with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are
credible” (ICH harmonized tripartite guideline for good clinical practice. (1997). Richmond,
Surrey).
19
in terms of qualifications or patient recruitment etc. Consequently, sponsors strive to make
informed decisions, giving the ability to predict the outcome and success of a trial (Harper, B.
D., & Zuckerman, D. 2006).
An article published in Applied Clinical Trials emphasises the importance for payer’s ability
to predict the success of a study and of a site (Demeter, 2002). According to the author, can
costs of aiding errors connected to site and investigator, once a trial is up and running be
greater than even closing it down completely and start from the beginning (Demeter, 2002).
Faults in the selection process can lead to low patient recruitment, lower quality of data and
other critical uncertainties. As the site and the study investigator are selected fairly early in
the planning of a study, predicting sites ability to successfully conduct a trial is essential for
the study outcome (Demeter, 2002). Evidently, a trial sponsor can gain significantly from
better predicating the success of a trial and as early as possible detect faults.
The Belgian study published in 2012 concluded that, based on the decisive factors, the main
obstacles for Belgium as country, was high costs together with challenging patient access.
Taking a closer look at the specific cost items, it is evident that operating cost charged by sites
together with investigator fees was the main concern for pharmaceutical companies when
considering Belgium as a trial country. This is consistent with Belgium not having any
implemented guidelines on trial costs, leading to a lack of transparency and variations in
charges by sites (Maes 2012). Moreover, difficulties in patient access was another main
hurdle for Belgium in terms of attracting new clinical trials. Belgium has, in contrast to
Sweden, many patients on a comparatively small geographical area. Nonetheless does barriers
in identifying and contacting these patients still exists. Mainly is this due to the patients being
spread over diverse hospital sites and a lack of patient organisations or similar to connect
patients. Furthermore, industry sponsors and other clinical trials performers express concerns
in low referral rates and an absence of tools, such as databases and portals, to support this
process (Maes 2012). Rated as a specific positive features for Belgium among the key drivers
of decision for choosing the country, was its good performance in approval timelines.
Belgium has an average approval time of 12 days for Phase I and 22 days for Phase II- IV
studies (Maes, 2012). Moreover, Belgium was also considered an option for location of
studies by the respondents due to the counties many specialised centres with specific expertise
and know-how in the field. In combination with good access to specific, niched patient
populations trough these centres, this provides Belgium with a favourable position in country
selection, notwithstanding its small population size (Maes, 2012).
External environment
A study conducted in Italy provides us with insights into what influences pharmaceutical and
biotech companies when locating their R&D efforts in drug development, including their
clinical trials. The study aimed to create a framework with variables influencing where
companies locate their R&D, incorporating both own in-house R&D and outsourced R&D
(Jommi & Paruzzolo, 2007). The authors classify the variables into four categories.
Regulatory environment includes variables such as the participation of the industry in the
decision-making processes surrounding regulations and transparency and speed of regulation
20
policies. Institutional framework includes corporate governance, how risk-oriented the market
is, as well as quality, flexibility and costs of workforce. Policies includes variables such as IP
landscape (in terms of patent protection), price and reimbursements and competitive
dynamics. National systems of innovation incorporate level of interaction among academia,
research and the industry as well as public investments in R&D and public support in
technology transfer and incentives for private R&D as level of public-private partnerships. In
national systems of innovation and local development and specialisation the authors include
the county’s local development in terms of GDP, infrastructure as well as if there is a clusterbased, sector-specific or general-purpose specialisation in the region.
Although, these categories are generalizing and the factors divided into each of them are
created for localisation of medical R&D in general, not explicitly for location of clinical trials.
Jommi and Paruzzolo (2007) concludes, that companies are drawn to settings that has a
structure that is open and non-hostile in terms of regulation. Further, the results gathered by
interviewing pharmaceutical companies in Italy and the Italian National Association of
Biotech Companies revealed that hospitals that have bureaucratic tendencies and lack
openness towards the private sector, causing a hold up the clinical trials processes. The
authors also problematize EU as a region, and argues there is an existing chasm between the
academia and the private sector, which in particularly applies to the biomedical field.
According to the study, there is a tendency for research to be limited to universities and public
research centres with a high speciality and a lack of interaction and knowledge exchange
between academia, medical practice and the industrial research (Jommi & Paruzzolo, 2007).
Noteworthy is that the framework developed by Jommi and Paruzzolo (2007) puts emphasis
on the underlying causes affecting location choice, which makes for a deeper understanding
of how to create a R&D environment for companies in medical development. The authors
make a distinction between public actions that has a direct or an indirect affect on how
location choice is made, facilitating the understanding of what will have an impact and on
what organizational level these actions needs to be taken. Direct influencing public policies
are for example the intellectual property landscape (primarily in terms of patent protection),
price regulations, investments made in research and other incentives aimed towards private
companies. Public actions that indirect influence how attractive a region is, are for example
infrastructure and the growth rate of GDP (Jommi & Paruzzolo, 2007).
In 2006 A.T. Kearney, a global management consulting firm, published a report presenting a
framework for ranking the attractiveness of clinical trials locations, by constructing a Country
Attractiveness Index for Clinical Trials. The objective was to give decision makers in
pharmaceutical development better information on where to off shore future clinical trials.
These is, according to the authors, an evident need for such an index as, pharmaceutical
companies in many cases base their decisions on trial locations on already existing
relationships and subjective knowledge about countries and regions (A.T. Kearney, 2006). It
is important to take into consideration that the framework was developed from an American
point of view with the objective to to primarily rank low-cost countries in relation to each
other. The index was constructed using five dimensions, critical for pharmaceutical
21
companies when selecting trial locations, according to A.T. Kearney (2006). The five
categories all consisted of several sub-categories and was weighted to their relative impact on
decision. The five areas forming the index are patient availability, cost efficiency, relevant
expertise, regulatory conditions and national infrastructure. The framework is presented in
full in Table 3, below. By evaluating these five areas, using United States, Germany and the
United Kingdom as a baseline A.T. Kearney are able to rank countries in order of
attractiveness for clinical trials. It can be concluded that the factor patient availability is given
the major weight in the framework.
Area
Patient
availability
Cost
efficiency
Relevant
expertise
Regulatory
conditions
National
infrastructure
Number of
clinical
research
organisations
Number of
clinical trials
Size and
availability of
labour force
with relevant
skills
15
Perspective of
the U.S Food
and Drug
Administration
Regulatory
laws
Strength of
Intellectual
Property
protection
Protection of
intellectual
property
Level of health
care
infrastructure
Level of
country
infrastructure
Country risk
factors
15
Categories
Patient pool
size
Patient
availability
Cost of
labour
Cost of
facilities
Travel
costs
Weight (%)
30
20
20
Table 3. Framework for Country Attractiveness Index for Clinical Trials developed by A.T. Kearney, (2006).
Important factors in relation to Sweden
A Swedish analysis conducted by The Boston Consulting Group in 2014 gave an overview of
factors affecting the Swedish ecosystem for clinical trials. Interviews was made from both an
industry perspective with representatives from pharmaceutical companies, CRO`s and
Medical Technology companies. Additionally, Regional Research Centres, Healthcare and
Academia was interviewed and the patient perspective was seen to by representatives from
patient organizations (The Boston Consulting Group, 2015). From the pharmaceutical
industry’s perspective, the result was divided into three groups Time to set-up trials, Quality
in execution and Link to promotion (The Boston Consulting Group, 2015). The most
important factors were shown to be time related, such as ability to complete a trial in a
qualitative and timely manner, harmonized and coordinated feasibility applications, as little
bureaucracy as feasible, a quick approval process and ability to recruit patients and sites
quickly was among the top determining factors for the industry. In relation to this, it could
also be understood that Sweden as country are in need of improvements specifically
considered feasibility studies and approval times. The second group of factors relating to
execution, showed that the presence and access to Key Opinion Leaders (KOL´s)4 and
4
“Traditionally, KOL´s have been healthcare professionals with senior positions in the medical community of
interest. They advise companies as to where unmet medical needs lie, choose drug targets, help to define
22
qualified investigators was key factors. This conclusion is in alignment with other literature
on the subject, for example Demeter (2002) points to the importance of the investigators,
claiming most companies put most effort into investigator selection, as
“the investigator’s knowledge and expertise is the factor of primary importance, followed
closely by the quality of the site staff and its infrastructure” (Demeter, Selecting sites and
investigators. Applied Clinical Trials 2002).
Further, the availability of diagnostics, technology and applicable data was considered to be
key elements for industry actors according to the study made by The Boston Consulting
Group. According to the study, Sweden have an advantageous position in these aspects, in
particular in execution of studies and access to data and equipment. The third group related to
promotion, here it was evident that an early launch on important markets was key, inherently
for trials in a later phase the commercial potential was a significant factor (The Boston
Consulting Group, 2015).
In Table 4 below, is a summary of the factors concluded to be most essential for companies’
willingness to conduct clinical trials in a country presented.
potential product profiles and shape clinical programs, run clinical trials, and may be involved in a drug’s
regulatory or reimbursement review process.” (GBI Research, 2012)
23
DEMOGRAPHY
INFRASTRUCTURE
ECOSYSTEM
Prevalence /Market size
Availability of facilities
Transparency
Access to patients
Technology access
Public/Private Interaction
Non-bureaucracy
Networks
Frequency of clinical trials
Proven success
Competence of authorities
COST
TIME
SITE
INVESTIGATOR
Transparency
Speed of approval
Quality
Merits/Experience
Standardisation
Time to initiate
Adherence to GCP
Interest
Experience/ Training
Key Opinion Leaders
Early launch on key
markets
Table 4. Summary of factors considered most essential for companies’ willingness to conduct clinical trials in a
country.
24
5.2 The Pharmaceutical Development Landscape
Pharmaceutical development is for many reasons a complex business area. The industry
engages many different actors which are more or less dependent on each other. Companies,
universities, research centres, public institutions, the health care system and patients are all
affected. Further complexity is added as the industry actors range from large global, million
dollar businesses to small, local firms (Gambardella et al. 2000). An increased demand on the
health care systems together with increased requirements for approval or new medicines,
among other things, made for a larger market complexity and affected how the
pharmaceutical industry are undertaking new research and development (Pwc, 2015).
Figure 2. Actors map comprising actors key strengths and objectives, adapted from Khanna, I. (2012).
A Changing Landscape
Demographic changes, in terms of an ageing population together with increased regulatory
demands and high failure rates has pushed the pharmaceutical industry to reassess and
develop their R&D strategies, to increase efficiency and output (Khanna, I. 2012). A decline
in innovation and success rate in new drug discoveries in both small and large pharmaceutical
companies could be seen during the 2000s. Within large pharma, Khanna (2012) argues the
decline is caused by various elements such as rigid organizations, increased mergers and an
uncertainty that encourages short-sightedness and lack of a long-terms planning, leading to
shorter timelines in projects (Khanna, 2012).
25
The change in the pharmaceutical development landscape has made companies alter their
strategies. A shift towards more complicated and complex indications can be found and the
larger companies has made an increase in big trials on a more international basis
(Gambardella et al. 2000).
Outsourcing of clinical trials to Clinical Research Organizations has increased dramatically
over the last decades, according to Evens has ”CROs offered the industry clients the ability to
outscourse various activites as the need arises. The contract concept has been applied to
manufacturing, development (preclinical and clinical), and business (e .g sales, market
research) functions in the pharmaceutical industry” (Evens, R. (2007). Drug and biological
development. New York: Springer).
Some of the most successful CRO companies has expanded on a global scale and evolved into
billion dollar businesses. Nowadays, CROs are not only limiting their businesses to
conducting clinical trials but has developed expertise in areas such as safety monitoring, data
management, statistical- and regulatory services (Lowman, Trott, Hoecht, & Sellam, 2012).
Although a shift in how pharmaceutical companies engage with CROs has been seen during
recent years. Pharmaceutical companies seem to increasingly collaborate with only one or few
preferred Clinical Research Organizations. Further, instead of fully outsource, companies to a
larger extent employs sub-contracting for specific parts of development. This to further
control costs and increase own access to technologies and knowledge developed (Khanna,
2012). Though, according to the Tufts Center for the Study of Drug Development Outlook
report for 2015, will Pharmaceutical companies increasingly use outsourcing as a part of their
activities but to a larger extend try out and validate different kinds of models for outsourcing
to find the optimal model to increase quality and decrease costs (Tufts Center for the Study of
Drug Development, 2015).
A growing number of companies are also seeing value in so called “quick win, fail fast”
strategies for clinical phases (Khanna, 2012). Getting a new medicine trough clinical and
approval phase increased with an average of 18 months, from 77 months in the late 1990s to
95 months during the 2000s (Khanna, 2012). An “quick win, fail fast” strategy increases the
ability to make fast and early decisions on whether to move forward or not with a specific
clinical molecule, saving expenses on an excessive clinical trials process. Example of this is
the Eli Lilly “Chorus” an initiative to ease and speed up the way for early-stage compounds to
reach the proof-of-concept phase faster and cheaper. This is done by a combination of new
management methods and more concentrated Phase I and proof of concept trials ("Lilly,
Chorus", 2016).
26
As an effect of a challenged and changed market new kinds of collaborations and partnerships
has emerged. Both private open-innovation initiatives such as the Astra Zeneca Bioventure
Hub ("BioVentureHub", 2016) or the Lilly Open Innovation Drug Discovery (OIDD)
Program ("Open Innovation Drug Discovery", 2016) has sprung in resent years. Increased
investment in public-private collaborations can also be seen such as the Critical Path Institute
(C-Path) founded by the FDA and and involves among others Universities, Research
organisations and Pharmaceutical companies. The consortium includes projects such as
creating of new data- and measurement standards to help evaluate efficacy and safety of novel
therapies ("Critical Path Institute", 2016). All of the above mentioned are examples on how
the pharmaceutical industry has been and still are adapting to a changed business reality and
are developing novel business models to keep up with an increasingly competitive market.
5.3 External channels for information
Numerous means exist by which a clinical
trials sponsor and/or performer encounter
information on potential trials locations,
hence isolating specific information channels is difficult. In this section focus will be put on
different channels for information, specifically on certain trends and changes that can be
noticed in how clinical trials sponsors and/or performers acquires information and
interconnects with the public and other stakeholders.
5.4 Patient recruitment
One of the most challenging aspects of running a clinical trial, and the most common reason
for delays, is managing to enrol enough patients and to succeed in engaging experienced
investigators (Harper, B. D., & Zuckerman, D. 2006), (Shampine, 2016). A constant difficulty
for sponsors and performers of clinical trials is identify and recruit the right patients to
studies. A vast amount of studies fails to recruit enough patients within the time limit,
creating hurdles for an already pressured industry with an increased number of competing
trials, while a decrease in number of eligible new investigators (Kremidas, 2011). Further
complicating the recruitment of patients is the increased focus on personalized therapies,
targeting a specific, often limited patient population (Jensen, 2015), (Miseta, 2013).
Why trials fail to enrol enough patients in time may in large be due to insufficient
information, clinical trials sponsors and performers may not have enough knowledge to make
a correct and fitting choice of study location (Miseta, 2013).
27
Forthcoming a clinical trial, a rigorous selection process is performed by the sponsor and/or
their subcontracting partner. Vital information gathering on suiting trial countries and
appropriate sites is done by conducting a feasibility study. A feasibility study may look
different dependent on the sponsor and/or performer of the clinical trial, the indication
investigated and the clinical phase, but is in short terms an analysis of the preconditions and
prospects of conducting a trial (Kibby, M. 2011). A feasibility study incorporates strategic,
scientific and methodological aspects essential to conducting the trial. Examples of such
factors are number of eligible patients, number of clinics and their respective recourses. A
proper feasibility study is a central part to assure cost effectiveness, patient enrolment and the
quality of the data gathered (Jensen, 2015). Assessing a site´s experience, facilities and other
abilities that fulfil the need of a specific trial can be made trough, for example a questionnaire.
The questionnaire is constructed by the sponsor or Clinical Research Organization (CRO) and
often sent direct to, and answered by each site. According to Kibby (2011), the process may
look different depending on the Sponsor or CRO´s needs and objectives, but a common
approach for feasibility can be described as the following:
1. A Medical specialists confirm the protocol5 design.
2. The Sponsor or CRO evaluates logistical considerations.
3. Sponsor or CRO investigate sites to ensure patient recruitment possibilities and
additional factors crucial for execution of the trial (Kibby 2011).
As for Sweden specifically, feasibility studies are mentioned as a bottleneck, hindering the
country from attaining studies due to the long time to process together with long time for
actual trial set up (Jensen, S. 2015), (The Boston Consulting Group. 2015).
It is evident that feasibility studies are both time-consuming and often fail to cover all aspects
of patient recruitment. (Quartley, 2016).
5
“The written description of a clinical study. It includes the study's objectives, design, and methods. It may also
include relevant scientific background and statistical information.” (Glossary of Common Site Terms ClinicalTrials.gov. 2016).
28
To achieve more accurate feasibility studies, dodge unnecessary expenses, reduce risk and
increase efficiency in their feasibility studies an increased amount of clinical trials sponsors
are turning to decision support technologies and tools for predictive analysis (Holford, N. H.,
Kimko, H. C., Monteleone, J. P. R., & Peck, C. C. 2000), (Shampine, 2016). This can be done
by trial simulation which allows the performer to create realistic scenarios by using data on
potential trial countries and sites. Rapid development and use of big data solutions has made
simulation more effective and gives the user the ability to generalize and make decisions on
complex and complicated matters where many factors needs to be taken into consideration,
before a vast amount of time and recourses are spent on conducting an actual trial (Holford,
N. H., Kimko, H. C., Monteleone, J. P. R., & Peck, C. C. 2000). Simulation is applied on
many areas in clinical development, such as for development of new active molecules, to
support proof on concept as well as for use in the clinical trial process to optimise trial design
and outcome (Girard, P., Cucherat, M., & Guez, D. 2004). A simulation can also be made to
asses the most appropriate countries and/or sites to fit a specific trial design. Analysis can
either be done beforehand, using prior collected data and experiences from previous trials to
use as a knowledge base before a feasibility study. The simulation can also be used in
combination with a concrete feasibility study made on the site, to set realistic expectations on
recruitment process and mitigate risks. On a site basis, statistics included in the analysis
comprises, among other things, type of site, previous delays or success in patient recruitment,
delays in training etc. Analysis can also be made on a country level, based on regulations,
timeframes and other parameters specific for the country assessed (Shampine, 2016).
29
5.5 Channels for knowledge and information sharing
Initiatives to attract clinical business
As stated previously in this report, several countries have introduced various kinds of
initiatives to attract clinical business, research and increase the amount of clinical trials within
the country, either privately initiated or governmentally supported. When investigating how
these initiatives are being presented and communicated towards the industry some common
threads are found. The primary source for information appears to be via websites, presenting
the initiatives, its objectives and involved stakeholders. A key source for communicating new
information and progress seems to be a website Newsfeed as well as a regularly distributed
online newsletter sent to interested parties.
Moreover, reports and brochures published as part of the initiative seems to be additional
source of communication to attract general pharmaceutical business, including clinical trials.
An example of this is the Danish report Start with Denmark- The hearth of Life Sciences for
Research and Business (Ministry of Foreign Affairs, 2015), a report composed by, among
others, the Ministry of Health, Ministry of Foreign Affairs of Denmark, Ministry of Business
& Growth, The 5 Danish Regions, Danish Association of the Pharmaceutical Industry (LIF)
and the industry association for medical device companies in Denmark (Medicoindustrien).
The report is aimed at the Life Science industry to attract pharmaceutical business and clinical
research and argues for the advantages of the Danish environment. In the report arguments for
“choosing Denmark for research and business activities within the pharmaceutical industry,
the medical technology industry and the eHealth industry” (Ministry of Foreign Affairs,
2015), are presented, whereof, 4 out of 10 reasons highlighted can be directly linked to the
beneficial conditions for running clinical trials in Denmark.
A common nominator for these sort of initiatives is that the largely are structured and
communicated as a cooperation between public and private actors. Furthermore, are they
characterised by an emphasis on some particular areas. When looking into the language used
and what is communicated some common themes can be found:
-
-
Emphasis on attracting clinical research, rather than clinical trials. An increased
amount of clinical trials is secondary to attracting pharmaceutical and medical
technology business to the country.
A focus on public-private partnerships and collaborations, with for example the
academia.
Attention upon the patient benefits of increased amount clinical trials.
Emphasis on the countries ability to absorb new therapies fast in general practicing.
30
Social media as a channel for information and knowledge sharing
When investigating external channels for information, it is evident that digital channels such
as web sites and newsletters has been used for a while, and still are one of the primary sources
for information. Although, a new arena for communication increasingly implemented by
industries and businesses is social media.
Social media is defined as “websites, technologies and software applications used
interactively to communicate and share information” Lamberti, M., Stergiopoulos, S., Naik,
P., & Getz, K. (2014). Industry Usage of Social and Digital Media Communities in Clinical
Research. The Tufts Center for the Study of Drug Development.
According to Allison (2010), social media has not yet revealed its full potential within clinical
research. Although, there is a common view within the industry that alongside the
development of technology and Big Data solutions, many improvements will follow.
Communication and data collection before, during and after clinical trials with both the
researchers and patient community will be enhanced by the use of social media (Allison,
2010). The use of social media is still not as fully adopted as useful tools within the
pharmaceutical and life science industries as in many other business areas. This is due to
several uncertainties, neither does the U.S. Food and Drug Administration (FDA) nor the
European Medicines Agency (EMA) yet have any guidelines or policies recommending the
pharmaceutical industry on use of social media in clinical research. FDA has addressed this
issue in part by developing some guidance documents, which are not legally binding, with the
agency’s view on topics such as a guidance document for marketing via twitter or online paid
searches (via e.g. Google) or a draft guidance on:
“FDA’s current thinking about how manufacturers, packers, and distributors (firms) of
prescription human and animal drugs (drugs) and medical devices for human use (devices
should respond, if they choose to respond, to misinformation related to a firm’s own FDAapproved or cleared products when that information is created or disseminated by
independent third parties on the Internet or through social media or other technological
venues (Internet/social media)” (U.S. Food and Drug Administration (FDA),. (2014).
Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party
Misinformation About Prescription Drugs and Medical Devices).
During 2013 The Tufts Center for the Study of Drug Development conducted a study on the
pharmaceutical industry´s use of social media, both as an inbound and outbound channel for
information. The study included both pharmaceutical companies, biotechnology companies
and CROs. From the report it was concluded that neither sponsors or CROs has developed
specific processes for social media use and communication, the media are rather being used
informally and uncoordinated within the firms. Although, a majority has implemented
guidelines on employees own use of social media. Sponsors of clinical trial are not commonly
using social media tools for their clinical research, but for commercial reasons as a marketing
tool. Moreover, is social media used as a tool to listen into the current debate amongst patients
and professionals. Further, a small part of asked companies reported they utilized social
31
media as a communication and recruitment tools towards patients. One in five companies
reported they used social media channels for direct communication with the patients. The
main reasons for not using social media was, among other, worries related to research biases
or that it would inspire drop-outs or violate privacy. The main concern among the respondents
was how to handle adverse event reporting that could occur online. From a regulatory and
legal perspective, direct to consumer communication restrictions, integrity issues in relation to
clinical trials, concerns of ownership of account and information are some of the main issues
that the industry need to approach. Nevertheless, respondent shared the common view that
social- and digital media as a channel for communication will increase its importance and
become frequently used to interact with and gather feedback from site personnel, health care
providers as well as patients and other stakeholders in clinical research. According to the
authors, this will instigate development of specific standard operating policies (SOPs),
policies as well as development of rules of conduct in relation to social media (Lamberti,
Stergiopoulos, Naik, & Getz, 2014).
Notwithstanding the concerns raised, several innovative companies has evolved with the
intention to utilize social media and social networking in clinical research. One approach is
trough online communities. One of the largest online communities are the patient platform
PatientsLikeMe ("PatientsLikeMe", 2016). The site has over 400.000 members interacting
and discussing more than 2500 different medical conditions. The platform for sharing health
data encourages members to share experiences, discuss, support each other and manage their
own medical conditions. The company behind the site clearly states that data (except
personally identifiable information, which requires specific consent) submitted by the users
are shared with the company partners including some of the largest industry actors such as
Merck, Novartis Boehringer Ingelheim and Astra Zeneca among many others. Sharing and
selling the user’s data PatientsLikeMe aim to bridge the gap between patients and the industry
by increased understanding of patients needs and experiences, ultimately increase research
and enhance the development of new patient solutions ("PatientsLikeMe", 2016). In addition
to an online community, the site also provides information on clinical trials and an extensive
search engine for recruitment. Both, companies and public researchers use the site to recruit
individuals to participate in studies. As of 2 May 2016, 169 clinical trials recruiting or about
to start recruiting in Sweden can be identified using the PatientsLikeMe search engine
(according to a search performed 2 May 2016 at "Clinical trials at PatientsLikeMe").
Moreover, there are similar social media solution aimed toward physician’s, the most
commonly known is Sermo, with over 550.000 members interacting. The site is used by
physicians to connect and share insights. The platform also allows industry actors to connect
with the large user base, by creating presentation pages, customized ads, sponsored posts or
other information directed toward the entire or parts of the community ("SERMO", 2016).
This is a possibility for the industry to support their clinical trials activities, by having the
ability engage with potential investigators, recruit experts to get direct feedback on trial- or
protocol design as well as conduct feasibility surveys ("SERMO", 2016), (Allison, 2010).
32
Networks and Partnerships
Publicly incentivised networks exist as arenas for information sharing and where the
conditions for managing clinical trials is in focus. There has been many such partnerships and
organizations initiated throughout the years, such as the The European Clinical Research
Infrastructure Network (ECRIN), that supports European multinational clinical trials
("ECRIN - European Clinical Research Infrastructure Network", 2016) or the Nordic Trial
Alliance (NTA) a collaboration between the Nordic countries between run as a pilot project
during 2013-2015 (“Nordic Trial Alliance” 2016). These forms of networks and
collaborations has undergone some criticism as to their purpose, function and usefulness. A
study made by the Nordic Innovation Centre amongst 39 stakeholders in the pharmaceuticaland life science industry as well as the public sector revealed that many didn’t considered the
local organizations of ECRIN to be successful. Many had not knowledge of the local
organisations such as the Swedish SweCRIN or or Danish DCRIN whatsoever and several of
the local organizations did not receive any further funding by ECRIN after year 2011(Eriksen
& Kierulf, 2010). According to the study, ECRIN has focused its recourses on internal, noncommunicational undertakings such as harmonization of regulations within Europe, to lay a
good foundation for future clinical trials in the area (Eriksen & Kierulf, 2010).
According to a study made by Tufts Center for the Study of Drug Development (2015),
pharmaceutical companies will increase their involvement in partnerships with academic
institutions, clinical research organisations and other entities, such as patient groups that will
benefit innovation, research and development efforts. There is nothing indicating costs for
medical development will stop to increase, rather the contrary as more information on
performance in relation to products already on the market is demanded by payers as well as an
increased demand for health economic benefits. Consequently, pharmaceutical companies are
increasingly searching for new ways to mend costs and manage risks. Partnerships with the
public sector and within the pharmaceutical industry will continue to develop in different
forms. Further, pre-competitive consortiums for development and risk sharing will increase
amongst drug developing companies, a great change for a traditionally very proprietary and
closed industry (Tufts Center for the Study of Drug Development, 2015).
33
In Table 5 below is a summary of some of the main channels for information access by
clinical trials sponsors presented.
SENDER
OUTPUT
National initiatives to attract clinical business
Websites
Brochures
Traditional media
Networks and Partnerships
Information sharing
Social media
Social Listening
Online communities
- Patients
- Medical professionals
Table 5. Channels for information access
34
5.6 Decision making
In this section the third stage of the process
model will be investigated, how and by whom
are the final decision on trial location is taken.
Studying the internal company processes in relation to decision making on trial locations,
reveals both similarities and differences in how various actors agrees upon final location for a
clinical trial.
The results of the Belgian study, consulting 53 different stakeholders within the clinical trials
area, revealed that when a pharmaceutical company conducts a study in-house, the decision
most often lies with the pharmaceutical head office, not with its local organizations (Maes
2012). In contrast, when a company is out-sourcing its clinical trials activities to a CRO, the
final decision making is more diffuse. It was concluded that in 56% of the cases is the
decision a joint one between the CRO and the sponsor. Very seldom is a final decision on trial
location made solely by a CRO (Maes 2012). When deciding upon investigator, a sponsor
relies largely on personal relationships and previous experience to identify the right
investigator for a clinical trial. According to Quartley (2016) experienced investigators are in
high demand due to the increase in number of competing trials and a decreasing rate of
investigators that stay for a longer period of time within the clinical trials sphere (Quartley,
2016). This may lead to that clinical trials sponsors to a larger extent must create new
relationships and develop abilities to identify and assess potential investigators on other forms
of characteristics such as personal motivation and ability to access and recruit patients. Table
6 displays a visualisation of a common decision making process, adapted from Demeter, J.
(2002).
ACTION
PERFORMER
Order of feasibility study
Clinical department (Sponsor)
Suggestion who should be country coordinator or PI
Market department (Sponsor)
Appointing of monitor to collect information
CRO
Conduction of feasibility interviews
Monitor
Decision on which centres to suggest
CRO Manager
Acceptance or rejection of suggestions
Sponsor
Table 6. Visualisation of a common decision making process, adapted from: Demeter, J. (2002). Selecting sites
and investigators. Applied Clinical Trials,11(3), 56-66.2002.
35
Although, many factors need to be taken into consideration by the sponsor and/or performer
of a clinical trial when deciding upon country, the relative importance of these factors will
vary, mainly dependent on the companies’ internal strategies, the actual study design,
complexity and the characteristics of the therapeutic area. The internal processes and decision
making are characterized by a high level of uncertainty. Decision are in many cases situation
based and dependent on each trials unique requirements. Internal decisions are to a high
degree built on previous experience as well as existing relationships with, for example
specific investigators (Quartley, 2016).
36
6. Result
On the following pages the results of the qualitative and quantitative data collection will be
presented. Focus will be on companies need, decision making and external channels for
information.
6.1 Qualitative Research
The qualitative method used for data collection exposed several key topics related to the main
question. As for strategies utilized by industry clinical trials sponsors and/or performers to
select country for a clinical trial, the qualitative study suggests that for larger pharmaceutical
companies, certain aspects can be identified as central for a majority of the respondents.
Historical data, indicating the country’s previous merits, was brought up by all the
respondents from the Large Pharmaceutical segment as being essential for why a specific
country is chosen. Two of the four respondents from large companies even stated that their
company always considers historical track record when selecting countries for upcoming
clinical trials. In contrast, respondents from the Small and Medium sized Pharmaceutical
companies was historical data not mentioned specifically as a factor influencing where
companies located their clinical trials activities. For these companies was quality the most
commonly mentioned factor to where to place a study. Interviewees commented that Sweden
is known for having high quality in clinical trials. Further, contacts and networks was
mentioned as crucial and a necessity for being able to initiate a clinical trial for the smaller
companies. As all the Small and Medium sized companies questioned was based in Sweden,
their contacts and networks was largely placed within the country. This was the main reason
for conducting a clinical trial with Sweden as primary location and not move the trial abroad,
irrespective of conditions in other countries. As for respondents from Clinical Research
Organisations, contacts and networks was mentioned as essential as well for where a clinical
trial would be placed. Although, for the CRO segment it was rather the contacts and networks
of their customers that was key as to where a trial would take place. Exemplified by one of
the respondents as such:
“As it is often the sponsor who has contact with expertise in the field, they have a bunch of
doctors who have contacts in the country, that is how I think you choose countries. If you
have an American sponsor who has a Medical Adviser who is friends with two French and
three German ones, then they choose Germany and France. But if they do not, they are
completely lost.” - Clinical research manager, CRO
Further, the ability to identify patients was mentioned by respondents from all sectors. From
the answers given, we get the understanding that identifying patients involves two separate
parts. One part is the volume of patients, which is a demographic factor relative the
therapeutic area and size of the study. Secondly, the ability to find the patients, and
specifically the right kind of patients in relation to the design of the trial.
37
Seven out of ten respondents mentioned the fact that Sweden has a limited population.
Although, a difference in opinion on this matter could be found. A total of five respondents,
from all segments, said a limited population may be a disadvantage for Sweden. Although,
two respondents from the Large Pharma argued this may not be as great disadvantage as one
may believe. One responded argued that it is seldom their company can not do studies in
Sweden due to a too small population sample. Another answer given, also from the Large
pharma segment, was refereeing to how Sweden in the 80´s and 90´s excelled within clinical
trials, which would be contradictive as the studies made in this period mainly was large
population studies in areas such as asthma and hypotension. Hence, a limited population size
may not be a main factor according to these respondents. It was by mentioned by a majority
of respondents from the Large Pharma segment that a change is how the company takes on
clinical trials has been seen in the later years, which evidently effects the types of patients
required.
“We are now, compared to then, carrying out a different type of clinical trials, we are in a
new phase where we are looking at very small patient groups and we have moved away from
these common diseases to subgroups of cancer and rare diseases, the whole trial world has
changed its ways” - Medical Director, Large Pharma
Mentioned by respondents from Large Pharmaceutical companies is the importance of Time,
which is directly linked to patient recruitment. Time, here simplified as how long it will take
to get a study up and running, including, but not limited to, receiving authorization from
governmental entities, recruiting sites as well as finding and enrolling the patients.
According to one respondent from the Large Pharmaceutical segment, did time become an
increasingly important aspect, as the pharmaceutical industry begun outsource its activities to
a larger extent by employing Clinical Research Organisations. According to the interviewee,
this can be connected to the increased influence by CROs, as their revenue model which is
based on how fast results can be delivered to the sponsor. Contrasting to this, the
representatives from Clinical Research Organisations interviewed did not mention time as an
explicit factor as to where clinical trials are placed. Neither did the interviewees from Small
and Medium sized Entities explicitly state time as an important factor. Although, time was
indirectly mentioned as a factor, for example has long contractual- and application processes a
negative effect on a country’s attractiveness for clinical trials according to respondents from
the CRO segment. Similar comments were made by a respondent from the SME segment,
who said to be using a mix of public and private clinics due to the perception that
administration takes less time in the private sector and the contractual process is shorter.
The qualitative data collection further revealed that Large “For Sweden to even be allowed
Pharmaceutical companies to a great extent are driven by in the game, we have these; 100%
recruitment, 100 days to get
hard metrics. For a country to be considered as location
started, and high quality” for a clinical trial it needs to fulfil specific criteria’s,
Research Director, Large Pharma
generally are these examined trough feasibility studies.
These metrics may look different depending on company,
clinical trail phase and the therapeutic area. Nonetheless does certain factors, such as ability to
38
recruit patients and time reoccur in most clinical stages and therapeutic areas. Table 7
displays a summary of factors essential for industry clinical trials sponsors and/or performers
selection of country for a clinical trial.
NEED
Historical data/
Track Record
SEGMENT
Large Pharma
RATIONAL
Speed
Large Pharma
Fulfil hard metrics
Large Pharma
How long it takes to get a trial up and
running
Generally examined in feasibility studies
Dependent on company, clinical phase
and therapeutic area
Identify Patients
All
Quality
SME
Contracts & Networks
SME
CRO
Short contractual- and
application processes
CRO
- Volume of patients, demographic factor
relative the therapeutic area and size of
trial.
-Ability to find the right kind of patients
in relation to the design of trial
If company is local, more probable to stay
if access to networks
CRO dependent on sponsors contacts and
networks
Table 7. Summary of factors essential for industry clinical trials sponsors and/or performers selection of country
for a clinical trial.
39
Decision making
Investigating how and by whom the final decision on where a clinical trials sponsor and/or
performer locates a study revealed some dissimilarities between the three segments.
According to the respondents from the Large Pharmaceutical organizations, is the internal
decision making process characterised by the final decision being taken at the international
head office. While Small and Medium sized companies seems to be more dependent on their
situation, the specific trial and contacts. This is pursuant to the before mentioned aspects
found to be most important for Small and Medium sized companies when selecting trial
countries. All interviewed companies conducting trials in the Small and Medium sized
companies said to be employing a CRO for their clinical trial activities.
When employing a CRO, regardless of company size, the final decision on trial location
would be made either solely by the sponsor, this was the most common practise, or by having
a dialogue with input from the CRO. Very seldom was decision made by the CRO solely.
This correlated with answers from interviews with actors from CRO companies. As an
example, one respondent stated:
“It's a bit different between projects sometimes the pharmaceutical company solely choose
which sites they want; they may already have a prepared list. But in the projects where we are
involved from start we can clearly influence, sometimes we are even paid to be involved in
producing a site list. Then it is basically we who decide which countries and sites based on
certain requirements of course and we also justify why we put forward the list.”- Project
Manager, CRO
A common nominator for all segments questioned was that having input from one or more
knowledgeable people in the therapeutic area was preferred and partly may have an effect on
the country, and even more so the site selection, especially for smaller actors.
“The further in development you get, the more strategic you must be. Not only get centres but
get the right centres, get the right investigator who has the right name. It is a part of your
lunching strategy, you want to have the right people behind it, who has been involved in the
studies and that can promote it. “ - Medical Affairs Director, SME Pharma
According to a majority of respondents from all segments is the final decision on countries
and trial sites is primarily based on results from feasibility studies6 conducted. The result from
the interviews with respondents from Large Pharmaceutical companies indicates that
feasibility studies are largely made in two steps, firstly on a country basis and secondly on site
basis. At the initial stage, inquiries concern the possibilities to conduct the trial within
country. The focus lays on prevalence, incidence, prospects, infrastructure and track record
from previous trial within a country. One respondent described this initial part as a marketing
analysis:
6
Feasibility is here used in a broad perspective, comprising several parts of information
gathering preceding a clinical trial.
40
“Country representatives will approach specialists in the field, in the best of cases we have
contacts, otherwise we find those who are leading the country and say; this Study protocol
will come, it is approximately this population we will look at, is it feasible in Sweden? Is there
interest? Simultaneously we look at Clinicaltrials.gov and see if there are conflicting studies,
they might already have absorbed the potential patients. Simply put, we do a market
analysis.” - Research Director, Big Pharma
If successful, the second part of the feasibility is concluded where the prospects for trial sites
is investigated. Questions asked concerns the ability to identify investigators and clinics in the
country. Specific sites need to evaluate how many patients they are probable to enrol, what is
possible to accomplish and what is not in relation to the study design. Site infrastructure,
technology and more, required for the specific trial is likewise investigated. This information
is packaged locally or regionally and delivered to the international head office where the data
is critically reviewed before final decision on trial countries is made.
The qualitative data collection revealed differences as well as similarities in how clinical trials
sponsor and/or performers choose and make decisions on where to place their trials activities.
According to one respondent from the Large Pharmaceutical sector, having the final decision
being taken at the international head office brings certain challenges to light, as the
international offices does not have much insight into the specific countries, placing extra
pressure on the local representatives to accumulate enough and correct material for an
informed decision.
As for the Small and Medium sized pharmaceutical companies taking part in the qualitative
study, questions on the process of deciding where the study will be placed gave various
answers. Similar feasibility studies are made but the responses indicate a more unstructured
process compared to the Large Pharma segment. In accordance with what was indicated by
this segment as being essential factors for choosing a specific country or site, the actual
decision process appears dependent on contacts and networks. Two out of four participants
claimed that the Principal Investigator had great influence on the decision where the study
was placed, mainly due to that individual´s connections to other countries, sites or relations to
other investigators in the field, which largely affected the final decision on where a trial was
situated.
41
External channels for information
“Many global pharmaceutical companies
Taking a closer look at opinions on what
have operations in Sweden so if you can
external channels a clinical trials sponsor
reach them, it will spread to the
and/or performer would encounter
headquarters. If they know locally within
information on locations to perform a trial,
global companies, then you have a way in
and what may impact them, resulted in
there, it may be difficult otherwise.” Project Manager, CRO
several categories with concrete suggestions
from the respondents. In the Large Pharmaceutical segment, it was apparent that the own
local or regional offices seemed like the most beneficial way to reach decision makers
globally, according to the results from the qualitative study.
“We must be involved in running it internally, you cannot just put out it as advertisement or
something, it must be done inside the firm. Denmark is preceding Sweden but it has not
affected the view here internally or on a global level. Sure, we see here, from our side, that we
would like to do studies with Denmark as a core country. But at the global level, it is not
obvious that the marketing has had any affect on how you do studies in Denmark. We know
that they are ahead, but outside Scandinavia I do not know how much you see of that part.”
- Clinical Operations Country Manager, Large Pharma
A need for material to support the feasibility and decision process described above was
expressed by several interviewees, both from the Large Pharma and CRO segment. Several
respondents welcome some kind of marketing material or standardized presentation material,
which they would be able to use internally and forward to their international head offices. By
one of the respondent was a portal suggested as a suiting platform for publishing this kind of
material. Further, respondents expressed a need for this material and other communication
material to be prepared in English. Similar needs to support the feasibility process were
uttered by respondents from Small and Medium sized pharmaceutical companies. Though not
as communication material but rather as a need for assistance to find country specific
information, such as knowledge about sites, information on prevalence and how to find the
patients, to support a feasibility process.
Interviewed individuals from both Large- and Small/Medium sized companies suggested to
make successful case studies and to use storytelling as a part of marketing Sweden. Especially
case studies within areas where Sweden may have a
“If you do not have a very evident
slightly unique position, such as quality registers. One ambassador it gets very difficult, to
only have a website or a platform to
respondents from the Large pharma segment meant
offer, it may work but I think that you
that further use case studies could be to demonstrate
will have much better response if you
that Sweden is not only excelling in small complex
have dedicated ambassadors.”
studies, but also has great competence in larger
- CEO. SME Pharma
therapeutic areas and to demonstrate Sweden’s ability
to enrol patients just as well as other, larger countries.
Furthermore, ambassadors or spokes persons were mentioned by several respondents from
both Large- and Small/Medium sized companies as a useful approach for communication.
One respondent emphasized the importance of finding ambassadors who has an understanding
42
of both the clinical side and drug development as well has holding knowledge of the business
context to be able to hold a conversation on a peer-to-peer basis with decision makers within
the pharmaceutical industry. These external channels are summarised in Table 8 below.
CHANNEL FOR
INFORMATION
Local Office
SEGMENT
NEED
Large Pharma
Arguments to influence HQ
Feasibility
Material to support feasibility
Feasibility
Large Pharma
CRO
SME
Story Telling
All
Case Studies and good examples
Ambassadors
All
Assistance to conduct feasibility
Table 8. Summary of preferred external channels for information
Challenges
Respondents from all segments commented on the
“If you are a decision maker at a
challenges connected to carrying out marketing in
pharmaceutical company you get
the pharmaceutical sector. Main concerns were
1000 emails a day, it is almost
related to the vast amount of information already in
impossible to get through the noise. If
motion regarding similar initiatives and offers from
someone calls you, you just get angry
and sales reps, that doesn’t work at
other countries and organizations. Although, the
all. So it is a challenge.”- CEO,
interviewees had differentiating opinions how this
SME Pharma
issue could be mitigated. Respondents from the
Large Pharma segment preferred a combination of tactics to communicate. A majority of
respondents from this segment argued for using several channels for marketing, such as
conferences, articles and spokes persons. Two respondents also emphasized that marketing
should not be limited to industry channels. Three of the interviewees further commented on
the fact that several other countries have introduced similar initiatives to promote and attract
clinical trials to their region. Another respondent argued that even tough several other
countries are doing heavy marketing and large investments in this area, Sweden must be on
the same arena and communicate similar efforts. The United Kingdom was mentioned as an
example, as they, according to one respondent, had used several channels including
conventional media, conferences and published articles in influential papers. Although,
respondents had diverse opinions if the United Kingdom initiative was to bee seen as a
marketing success. One respondent meant it took a long time for the pharmaceutical industry
too understand that the United Kingdom was making these efforts. While another respondent
from the same segment meant that Sweden should more or less cherry pick from what the
United Kingdom has made in terms of both internal organization and marketing.
Nevertheless, the common denominator for the Large Pharma segment was that a majority of
respondents preferred an intense and multifaceted strategy for marketing Sweden as an
attractive country for clinical trials. In contrast did a majority of respondents from Small and
43
Medium sized companies prefer a more specific marketing strategy. One respondent sought
for a differentiation between “Branding” of Sweden and “Marketing” of the Office for
Clinical Studies, Swedish Research Council´s initiative to attract clinical trials. Industry
conferences were used as example by two of the respondents in the Small and Medium sized
segment as a common channel by which similar initiatives and countries has marketed
themselves. This, according to the interviewees may not be a particularly effective approach
to neither gain attention nor attract new clinical trials business to the country, as one
respondent expressed:
“When I go on conferences, I have a pretty clear agenda who want to meet and I have not
particularly much over for these softer organizations, it is not in my interest at the time. And
there is nothing that they can say to get me to say; Aha but then we place our next trial in
your country… that depends on other factors.” – CEO, SME Pharma
Some respondents also expressed concerns related to the construction of a national web based
portal for clinical trials. It was stressed by respondents from the CRO and SME segments that
the challenge with establishing such a portal is to make it a useful tool and to acquire enough
site visitors. To link it to other sources of information, such as the Medical Products Agency
was said to be one key factor to direct visitors to such a portal.
A common element among interviewed individuals from Small/Medium and Large companies
was the importance of reputation and also to be able to differentiate Sweden from other
countries performing similar investments in Life Science and their clinical trials environment.
In connection to this, did respondents from both segments discuss Sweden’s history as a
successful nation within pharmaceutical development. What this history specifically entailed
or what impact it may have today could not be
“If a country has many publications, it will
given any well-defined answers. The
sooner or later break through, simply put,
importance of a high scientific profile, with
you get high status. That´s how it was earlier
renowned scientist and Key Opinion Leaders
when there were many PI´s from Sweden who
led these large studies and got into New
within specific therapeutic areas as well as a
England Journal of Medicine etc., it gives
high degree of academic publications was
certain branding to the country.” – CEO,
deemed important in relation to reputation by
SME Pharma
both Small/Medium and Large companies.
In relation to this did some respondents from the Large Pharma segment problematize the
relation between academic research and industry supported research in Sweden. Statements
made by two interviewees indicates these may be an internal perception within Sweden
regarding research conducted within an academic setting versus industry supported research.
This may, according to these respondents, negatively affect the ability to attract industry
clinical trials activities and research to Sweden, by for example which types of clinical studies
are prioritized within the health care. As for this, one respondent concluded that the Office for
Clinical Studies as well as the Regional Nodes has the possibility to demonstrate that same
value is given to all types of trials, no matter the setting. This can also be set in relation to that
it was also implied by respondents from both Large and Small/Medium sized companies that
in their experience, the clinics with a mix of academic and industry clinical trials was those
44
with the best results. Suggesting that a more even distribution may be beneficial for all types
of trials, as a more even flow of trials will give the ability to build up internal routines and
infrastructure. A negative perception on industry sponsored trials may also affect the ability to
employ reputable and prestigious researchers as principal investigators to sponsored trials. As
one responded stated:
“It's this thing, that academic research is fancier than sponsored research, the conversation
has to start there. We need these people to be front figures, to show that; Sweden is ahead in
this therapeutic area, let´s take them into the discussions. In this way Sweden has ability to
influence the design of development plans and protocols and to make them more tailored to
suits us, that part it very important.”- Clinical Project Leader, Large Pharma
All respondents, regardless of company type remarked on challenges with conducting clinical
trials within the Swedish health care system. It was
“This is the absolutely most
emphasised that there in several cases may be an
important, it´s a hell to get out
opportunity to conduct a clinical trial in Sweden but the
to the clinics and run studies”
ability to take on the trial within the healthcare is a
- CEO, SME Pharma
bottleneck, hindering launch. The main concerns related to shortage of clinics with ability to
take on a trial and a lack of time within the clinics and health care. One respondent said that
their company never conduct any clinical trials within the Swedish healthcare any longer, due
to these factors. Another respondent from the Large Pharma segment hypothesized the lack of
time for research is due to cut backs on costs within the health care in overall, putting
increased pressure on a system who’s primarily mission is to manage care, leading to clinical
research being less prioritized. This can also be connected to the previous mentioned fact that
several respondents indicated that there is a chasm between how industry and and academic
research are viewed by the health care, and may therefore be prioritized differently. As a
mitigation to this, it was mentioned by two respondents from the SME segment and one from
the CRO segment, that creating some sort of Study nurse position within the health care
would be beneficial. With the intention to support and unburden the personnel who needs to
divide their time between clinical work and conducing a trial.
It was noted by respondents from both Large and Small/Medium sized companies that to be
able to have an impact on decision makers and consequentially attract an increased amount of
clinical trials activities to the country, verification is fundamental. To demonstrate what has
been changed in terms of environment and conditions for executing clinical trials is central.
Further, to validate that such an initiative performs and is serving its purpose is equally
important. The emphasis should, according to respondents from both segments, be on the
change and how specific problems are solved or has been improved, to have the greatest
influence. Two respondents from the Large Pharma segment expressed concerns that the
organization of the Swedish initiative may face difficulties in demonstrating changes and
improvements made. These concerns related to how the new organization in part builds upon
already existing structures, such as the regional Nodes, which already has operation up and
running locally. As the nodes will in part have two functions, as a contracting party for
45
conducting clinical trials as well as a supportive function in the Clinical Trials Sweden
initiative.
Moreover, remarks from both Small/Medium sized companies as well as Large companies
maintained that there is a limited amount of time and resources to do such changes and to
build a momentum around the same. As one respondent indicated, the vast amount of reports
made and previous discussions held around what is required to create an optimal environment
for clinical trials in Sweden, which may not have been communicating enough concrete
improvements, has spawned a need to demonstrate fast results from the introduced initiative
led by the Office for Clinical Studies at the Swedish Research Council, to not loose
momentum and interest both from the public and from important stakeholders. Other
comments from the large pharma segment on this topic was related to how Sweden talks
about it selves. That other countries may be better at communicating its strategic efforts in
general and particularly efforts around clinical trials. This was suggested by two respondents
to have a cultural aspect to it. As it in Sweden may not be customary to positively promote
one self compared to other countries. As one respondent exemplified it in relation to the
English clinical trials initiative:
“We are bad at beating the big drum. This applies to all clinical research and life sciences
that everyone is talking about, that it has almost, historically speaking, not been really nice to
promote academic research or any research. But in a world of such great competition, I think
it is really important.” - Medical Director, Large Pharma
In relation to this, it was also mentioned by four out
of ten respondents, including all segments that
”Shall we continue to talk about how
bad it goes, then you need to be aware
Sweden has a self-image that may not always be
consistent with the reality. Especially was this linked that you will not attract any talents to
to how there may be a positive shift in clinical trials, this industry.” - Research Director,
Large Pharma
but internally in Sweden we still talk about a
problem and a downwards trend. As examples can be mentioned that from the Large Pharma
segment two of four respondents spontaneously talked about a positive trend and an increases
number of clinical trials conducted in Sweden by their companies. A majority of respondents
also concluded that, in a global perspective Sweden is not a much more expensive country for
conducting clinical trials compared to other countries. Additionally, has several other
countries increased their capabilities in terms of quality and delivery, consequently Sweden
might not hold an as strong advantage in this field any longer. These factors may as well not
correspond to how we traditionally have perceived ourselves as a country for pharmaceutical
business.
46
Moreover, a specific challenge for Sweden, brought
”We need to understand the
up spontaneously by one respondent from the Large
consequences of taking in 50 new trials pharma segment reasoned around the fact that
to Sweden, then we have an obligation
market potential for a pharmaceutical company is
to the Swedish patient population to
not only about the number of potential customers in
also provide the treatments.” a country but also if and when a new therapy will be
Research Director, Large Pharma
implemented in the health care. The respondent claimed that disproportionately many clinical
trials will not be placed in a country, if the sponsors does not see that market potential exists
in terms of if the medicine will be taken to market. This was also connected to the ethical
aspects of conducting clinical trials, as this may give patients access to therapies in the
forefront of research, but as the medicine is still undergoing trials, the access ends when the
trial is completed (unless otherwise agreed). If the therapy, once approved, does not get
implemented into the health care system, unrealistic expectations may have been created
towards the patients.
47
Table 9 presents a summary of the challenges mentioned during interviews and the
mitigations suggested by respondents.
CHALLENGE
SEGMENT
MITIGATION SUGGESTED BY
RESPONDENTS
Vast amount of information
Large Pharma Use several channels for marketing
from other countries and
Not limit to industry channels
organizations already in motion
Vast amount of information
from other countries and
organizations already in motion
SME
Specific marketing. Not Conferences
Differentiation between “Branding” and
“Marketing”
Make The Portal a useful tool
Acquire site visitors
CRO
SME
Link to other sources of information, e.g.
MPA
Reputation and Differentiation
Large Pharma
SME
High scientific profile
Key Opinion Leaders within specific
therapeutic areas
High degree of academic publications
Perception of academic research Large Pharma
vs industry supported research
in Sweden
Work for, and demonstrate same value for
all types of clinical trials.
Constrains on Swedish Health
Care
Lack in absorption of new
therapies
Verification
All
Appointed Study Nurses
Limited time and resources to
build momentum
Large Pharma
SME
How we in Sweden talk about
our selves
Large Pharma
Large Pharma
Large Pharma
SME
Demonstrate changes in environment and
conditions for executing clinical trials
Validate the initiative serves its purpose
Emphasis on how specific problems are
solved or improved
Emphasize our advantages
Learn from other countries
Table 9. Summary of challenges and mitigations suggested by respondents
48
6.2 Quantitative Research
The quantitative data collection in form of a web based survey, is based on answers from a
total of 22 respondents. As displayed in the figure below (Figure 3) 55% of the respondents
said to be working within a Large Pharmaceutical company, 23% categorized their
organization as Small/Medium Sized Pharmaceutical company, while 18% of respondents
said they belonged to a Clinical Research Organization and 4% entered the alternative “other”
and specified to be working with “National Medical Quality Registers operations
organisation”. A majority of respondents worked within more than one clinical phase,
whereof 18% worked within all 4 phases (I-IV). 95% of respondents said to be working
within clinical phase III. Full distribution of respondents in relation to clinical phase or
department they are working within can be seen in Figure 4 below.
Figure 3. Categorisation of respondents based on their organization
49
Figure 4. Categorisation of respondents based on clinical phase or department
The second part of the survey investigated country selection strategies, aspiring to outline
how a common country selection strategy for clinical trials can be described. The respondents
had the opportunity to, in free text, express their opinion on what main factors determinates
where their organization locates a study, 18 of the 22 respondents choose to specify this in the
form. The distribution if answers is presented in Table 10, below. For the CRO segment, all
respondents mentioned access to patients. A majority of respondents in this segments also
emphasized the importance of qualified investigators with access to the patients. As for Small
and Medium sized Entities, was speed of approval deemed as important by all respondents.
Further, did a majority from this segment stress the importance of quality as well as trackrecord in terms of if the participating sites/clinics has enrolled the number of patients
committed to in earlier trials. For Large Pharmaceutical companies, availability of patients
was the most common remark. A majority of respondents from this segment also commented
on the importance of speed, mainly in terms of start up times, time from final protocol to first
patient in and quick response to feasibility requests. Moreover, was costs deemed as
important by this segment as well as quality. Access to experienced and engaged investigators
and scientific expertise in the country was mentioned as an important factor by respondents
from all surveyed segments.
50
NEED
SEGMENT
Access to patients
CRO
Qualified investigators
CRO
RATIONAL
Speed of approval
Speed
SME
Start up times,
Large Pharma
Time from final protocol to
first patient in
Quick response to feasibility
requests
Quality
SME
Large Pharma
Historical data/
SME
Track Record
Availability of patients
Large Pharma
Engaged investigators &
Scientific expertise
All
Table 10. Factors factors essential for clinical trials sponsors and/or performers selection of country for a clinical
trial
51
In the next section of the survey, questions on decision making processes was asked. This to
increase the understanding of what characterises the internal decision making process within
these companies. According to the survey result, 67% of respondents agreed and 33%
strongly agreed that the process leading up to a decision on location of a clinical trial is made
in a predetermined/structured way by the company. As visualised in Figure 5 below, 41% of
respondents claimed that final decision on location is a committee decision. 41% of
respondents marked the option “other” and specified their options in the comment field. For
Large pharma, 3 respondents claimed that the final decision was taken by the global
headquarter abroad, while 1 responded from this segment argued the final decision is made by
Clinical Research Managers and the Clinical Research Associates (trial monitors) who
performs the validation. Within the CRO segment, 2 respondent stated that by whom the final
decision on trial location is made is dependent on the particular contract and the collaboration
with the sponsor company in question.
Figure 5. Final decision makers
In regards to who has the ability to impact the decision on clinical trial location, the
department of medical affairs was estimated to have the larges impact and secondly the
regulatory affairs. While marketing department appear to have low impact. Although, small
differences between the options and the low number of respondents makes it hard to draw a
clear conclusion to this question. As for the Large Pharma segment specifically, Clinical
Operations seems to have impact while local organisations appear to have low impact. In this
segment some respondents claimed that AROs and CROs may have impact if the complete
trial is outsourced. Further did one respondents from a Small/medium sized company remark:
52
“When using a CRO they need to be able to at least buy in to the countries/sites as they will
deliver on the agreed time plan and cannot commit unless they can influence the decision.”
The last section of the survey examined questions on information channels, with the purpose
to identify by what external channels the respondents may encounter information on possible
clinical trial locations. Survey participants was asked how they would be most likely to
acquire information if a country would make improvements to their clinical trials
environment. The full distribution of answers is presented in figure 6 below. In general, was
networking estimated to be the most probable channel for this information, followed by
industry news and papers. For the different segment specifically, it can be concluded that the
CRO segment gave various answers although, networking deemed most common as channel
for attaining information. From the SME segment it could also be concluded that networking
was the most common channel, followed by conferences. For evident reasons, least common
in this segment was attaining information by an own marketing company. Answers from the
Large Pharma segment indicated that networking was clearly the most common way to attain
information, followed by industry news and papers and own marketing companies. Least
common in this segments were direct marketing and social media. A summary of these
channels is presented in Table 11 below.
Figure 6. Most likely channels for information rated by respondents
53
CHANNEL FOR INFORMATION
SEGMENT
Networking
Industry news and papers
Conferences
Own Marketing Company
All
All
SME
Large Pharma
Table 11. Summary of channels for information
7. Conclusion
In the following section the result for the qualitative and the quantitative data collection will
be concluded and set in relation to the preceding literature study in each stage of the process.
Figure 7. Process of clinical trials location choice
Stage 1. Important Factors, Needs & Objectives
In the first stage the emphasis is laid on companies’ internal strategy and drivers behind
clinical trials location choice. Undoubtedly, this is dependent on each individual company´s
recourses, focus, aims etc. as well as the objective with conducting the clinical trial,
determined by trial phase and the indication studied. Although, based on the results from this
study, similarities as well as differences on a general level can been found.
It can be concluded that literature and previous studies in the field agrees on certain, general
level factors as being the main drivers behind clinical trials location choice. The factors
revealed to be most essential for companies’ willingness to conduct a clinical study in a
specific country consist of several sub-categories. Although, common nominators can be
identified, connected to high level factors such as demography, infrastructure and general
country ecosystem. Moreover, elements such as components associated to costs and time are
essential as well as site-specific factors such as quality in delivery, experience and adherence
to GCP. Aspects directly linked to the Principal Investigator was also deemed important in
previous studies, examples of this are the investigator´s own merits and interest as well as the
access to scientific expertise such as Key Opinion Leaders in the country. These conclusions
are in part in harmony with what came forward in the qualitative data collection made.
Historical data/Track record was brought up as an essential factor for the Large
Pharmaceutical segment and was in two of the cases always considered as a part in the
selection process. Although is could not be supported in the survey by respondents from the
54
Large Pharma segment, here did rather survey participants from the SME segment deem
historical data as important. Nevertheless, does track record and previous merits seem to have
sizeable impact for attracting future clinical trials to a country.
Further was the aspect of time, including aspects enclosed in previous literature, such as
receiving approval and time to set up a trial deemed as essential by interviewees and could be
confirmed by the survey result. Although, small differences in what explicit time aspects are
seen as most important can be detected. Common mentioned aspects are speed of approval
from governmental entities and time to start up as well as time from final protocol to first
patient in. The subject of feasibility studies and the importance for the sponsor to gain
information on specific elements of the study was further a common topic. Including factors
such time and plausible patient recruitment for the sites.
Quality and explicitly in relation to site´s delivery was determined as an important factor in
previous studies. This was supported by result from both the qualitative study as well as the
survey. Quality seems to be a more determining factor for the SME segment. This may be a
consequence of smaller companies having less recourses, less ability to impact and to control.
Smaller companies may also have less own experience from previous trials, making for more
dependence on each trial site´s individual performance. Further, was contacts and networks
said to be a necessity for being able to initiate a clinical trial for the smaller companies as well
as for CROs. This could not be directly confirmed by the survey results nor by previous
studies. Although, one can argue that this is an indirectly connected to access to patients, as
subsequently having the ability to identify and contact investigators who has suitable clinics
and can access the patients is correlated. This may especially apply to smaller companies. In
the qualitative study, all the Small and Medium sized companies was based in Sweden, hence
contacts and networks was mainly placed in the county. This was used as an argument for
conducting a clinical trial with Sweden as primary location and not move the trial abroad,
irrespective of conditions in other countries. Access to patients was deemed as essential by all
segments in interviews and supported by the results from the survey. The importance of
access to patients also was confirmed by previous literature studied. From the study it can be
concluded that ability to find patients are affecting the location choice in many aspects, the
table 12 below visualises how the different sources discusses the ability to find patients in
various ways, the common nominators is that these can be connected either to demography or
finding/enrolling the right kinds of patients. As for Sweden, in particular the demographic
factor may be more a challenge than for other countries. Hence, finding and enrolling the
patients and in particular the right patients in relation to the trial design may be even more
central for the country. Here Sweden has an opportunity to excel by using its advantages in
for example registers and by being a country in the forefront of technology.
55
Demography
Identify patients
Concluded from:
Volume of patients, relative
the therapeutic area and size
of study
Find right kind of patients,
relative design of trial
Qualitative data
Availability of patients
Prevalence/ Market size
Quantitative data
Access to patients
Previous literature
Table 12. Aspects integrated in ability to identify patients
It can be concluded that there is a need to have a clear view on the country´s preconditions in
relation to the clinical trial sponsor/performer needs and objectives. Clearly knowing the
precondition in terms of demography and prevalence is essential. Here Sweden needs to
exploit abilities to quickly find patients and particularly the right kind of patients that can be
enrolled in a trial.
A need to have a good track record from previous trials is important and this must be as
evident on a general country basis as for individual sites. To gain track record and build a
good reputation, confirm and communicate results on the above mentioned factors is
fundamental, to even be considered as a trial country. The access to Key Opinion Leaders and
Scientific experience in the country seems to be important. Likewise does a high degree of
academic publication seem to be positively affecting the ability to attract clinical trials to a
country. From the interviews made it came forward that on this matter Sweden appears to
have some internal questions to look into, as for how the academy, industry and health care
interact with each other.
Stage 2. Information Gathering
The second stage in the developed model entails how clinical trials sponsors and/or
performers gather information to support their process leading up to a decision on where a
clinical trial finally will be placed. The goal is to understand the type of information needed
and by what channels that information may reach the decision maker in the best way possible.
The increased demand on both the industry and the health care systems along with
demographic changes and other challenges has changed the landscape for pharmaceutical
development. A shift towards more complicated and complex indications and changes in how
companies takes on clinical trials has been seen. This was also partly confirmed by the
qualitative analysis, where several respondents from the Large Pharmaceutical sector
confirmed a change is how the company takes on clinical trials can be seen in the later years.
It can be concluded from the study that patient recruitment seems to be a main challenge for
the pharmaceutical industry, irrespective of company type. This was also confirmed by
previous literature and studies made. Closely connected to the ability to enrol patients is the
preceding feasibility studies which, relative to the study design, estimates number of eligible
patients, number of clinics and their respective recourses etc. If the feasibility study fails to
56
predict or overestimates the ability to enrol patients this hugely affects the outcome of the
trial. The result from the interviews with respondents from Large Pharmaceutical companies
indicates that feasibility studies are largely made in two steps, firstly on a country basis and
secondly on site basis.
It can further be concluded that the need from clinical trials sponsors and/or performers is to
gain correct information and to gain this information fast. For a country to be considered as
location for a clinical trial it needs to fulfil certain factors, such as ability to recruit patients
and speed in processes. There’s a need to support the smaller companies in their feasibility
investigation, with contacts to sites, investigators and scientific expertise.
In terms of by what channels initiatives, changes and information should be communicated,
Numerous means exist by which sponsor and/or performer encounter information on potential
trials locations, hence isolating specific information channels is very difficult.
When investigating how other, similar initiatives to the Office for Clinical Trials, are being
presented. The primary source for information appears to be via websites, presenting the
initiatives, its objectives and involved stakeholders. Moreover, reports and brochures
published as part of the initiative seems to be additional source of communication to attract
general pharmaceutical business, including clinical trials. Although, weather these similar
initiatives could be seen as a marketing success was questioned in the qualitative study.
Survey participants was asked how they would be most likely to acquire information if a
country would make improvements to their clinical trials environment. In general, was
networking estimated to be the most probable channel for this information, followed by
industry news and papers. Answers from the Large Pharma segment indicated that networking
was clearly the most common way to attain information, followed by industry news and
papers and own marketing companies. Least common in this segments were direct marketing
and social media. The fact that direct marketing was deemed as one of the least probable
ways, by all segments may suggest the primary emphasis should be put on other channels.
Networks both on a local, regional as well as an international level deems important.
Especially for smaller companies, as it heightens the ability to find potential study sites and
qualified investigators in the field. It could be concluded that both private and Publicly
incentivised networks have taken an increased role as place for information sharing and
support. Although, it can be concluded that publicly incentivised organizations and initiatives
has undergone some criticism as to their purpose, function and usefulness. These thoughts are
in part confirmed in the in-depth interviews made as respondents expressed concerns
regarding the ability to show validation of the Swedish system and that the initiative is
serving its purpose. For Sweden to broaden its involvement in partnerships and networks, on
all levels but specifically to access scientific expertise, would moreover be beneficial to
attract new clinical trial business. This as having input from one or more knowledgeable
people in the therapeutic area may have an effect on the country selection, and even more so
the site selection, especially for smaller actors.
57
The need for networks can also be seen in terms of the increased use of social media
platforms, both from the side of the patients as well as for clinicians. This is a possibility for
the industry to gain insights directly from the patient community as well as support their
clinical trials activities, by having the ability engage with potential investigators, recruit
experts to get direct feedback on trial- or protocol design as well as conduct feasibility
surveys.
It was suggested by respondents in the qualitative study that the increased use of social media
and other technologies such as risk based monitoring, may be beneficial for Sweden. This, as
the country in many ways are ahead in terms of technology adaption and the general public
are generally positive to new technology including social media channels. An increased use of
social media within the pharmaceutical industry, both as an in inbound and outbound channel
was also concluded in the literature study. Although, specific guidelines and industry
standards are missing, making the use still limited. Nevertheless, social- and digital media as
a channel for communication will most probably increase its importance and become
frequently used to interact with and gather feedback from site personnel, health care providers
as well as patients and other stakeholders in clinical research. Advances such as the
capabilities to analyse and integrate data by the integration of electronic medical records with
software for electronic data capture, will benefit the industry. As well as the use of risk based
monitoring. Here Sweden can excel and benefit from its highly skilled site personnel with
often good understanding of technology. The country can be a pioneer by adapting to the
changed technology landscape, to increasingly attract clinical trials.
Stage 3. Decision making process
As seen in the model, the next part takes a look into how and by whom the internal decision
making process is conducted, after the supportive information is gathered. The focus is to
understand who has the ability to impact and how these would best be supported in the
decision.
The internal processes and decision making are characterized by a high level of uncertainty.
Decision are in many cases situation based and dependent on each trials unique requirements.
It can be concluded that when a Large a pharmaceutical company conducts a study in-house,
the decision most often lies with the pharmaceutical head office, not with its local
organizations. This makes for other types of challenges, as as the international offices does
not have much insight into the specific countries, placing extra pressure on the local
representatives to accumulate enough and correct material for an informed decision. Here
marketing material and arguments is needed to support local representatives and consequently
attract clinical trials from the larger players on the market. For Sweden in particular these
could entail country specific arguments such as the social security numbers and the many well
developed national registers etc. Which is a well known fact within the country, but may not
have reached an international level.
58
Internal decisions are to a high degree built on previous experience as well as existing
relationships with, for example specific investigators. When deciding upon investigator, a
sponsor relies largely on personal relationships and previous experience to identify the right
investigator for a clinical trial, this was evident especially for the SME segment. Here the
Principal Investigator had great influence on the decision where the study was placed, mainly
due to that individual´s connections to other countries, sites or relations to other investigators
in the field, which largely affected the final decision on where a trial was situated. This
indicates a more unstructured process compared to the Large Pharma segment and, in
accordance with what was indicated as essential factors for choosing a specific country or
site, appears dependent on contacts and networks.
Stage 4. Trial Start
Lastly, to be able to support the previous parts in the process certain actions may need to be
taken during and after trial start. As came forward in the study, the potential market size is
part in what industry actors let affect where a clinical trial is conducted. The market size as
such is dependent on prevalence and populations size. Though, as mentioned by one
respondent in the qualitative study to be able to take on newly developed therapies faster is
beneficial not only for the patients but will put the country forward in terms of attracting
clinical trials. Here Sweden should investigate its abilities to absorb new therapies into the
health care system.
59
Impact opportunities
In the next section, suggestions on how external input can be strategically formulated are
presented, to positively influence companies’ choice of trial location, based on their need and
objectives in the various stages of the process. The general impact opportunities on the
process of clinical trials location choice is visualised in Figure 8 below. By understanding this
can external actor’s such as the Office for Clinical Studies, Swedish Research Council get
support in their ability to give clinical trials sponsors/performers the right information at the
right stage, and consequently attract clinical trials.
Figure 8. Impact opportunities on the process of clinical trials location choice
On following pages will conclusions based on the performed study be presented together with
recommendations how to use these to have positive impact on industry clinical trial´s
sponsors and/or performers.
60
Stage 1
Conclusion
Important factors
Historical data/Track record
Time
Quality
Ability to find patients
Recommendation & Rational
Collect exemplary cases where Sweden has
excelled in relation to these factors.
Especially important in relation to ability to
find patients
-
Differentiate between Branding and Marketing
Branding of Sweden
Sweden should be superior in rapidly
identifying the right kind of patients in
relation to trial design, by utilizing our
internal resources and an interconnected
health care. Although, increased
collaboration across county borders is
essential to succeed
Emphasize Sweden as a research country
-
Utilize “traditional” marketing channels,
such as industry news & papers,
conferences, networks as well as nonindustry related media
Story telling and case studies
-
Use storytelling as part of branding,
especially within areas where the country
may have a unique position, such as quality
registers
Academic publications are important.
-
Encourage increased academic
collaborations.
Emphasise Swedish research in
communication
61
Marketing of Clinical Studies Sweden and the
Office for Clinical Studies
Results are essential
-
Pilot projects before marketing campaign to
prove validity
Identify where Sweden is unique and
differentiate Sweden in all communication
material, e.g.
-
-
Social security numbers
Registers
Low drop out rate in trials
High technology standard and highly
educated personnel on sites and in
healthcare
Transparency on all levels incl. costs
Important to not be perceived as solely an
initiative from the pharmaceutical industry
-
External environment
Change in business models
Increase partaking from Healthcare and
academic actors.
Emphasize multidisciplinary collaboration in
all communicated material
Shift towards smaller indications and more
complex studies
-
Highlight and profile Sweden in this area
62
New ways to gather information and engage
stakeholders
New technologies to predict outcome as
well as increased use of Risk based
Monitoring
-
-
Look into possibilities to be in the forefront,
otherwise risk to be overtaken by the
technology
Highlight Sweden’s fast technology
adaptation
Increased use of social media to engage and
communicate with patients and medical
expertise
-
May be beneficial for Sweden, as the
country in many ways are ahead in terms of
technology adaption and the public
generally is positive to new technology,
including social media
-
Although, ethical aspects need to be taken
into careful consideration
63
Internal environment
Internal communication & Self image
We still talk about a problem
-
Communication should be positive to
attract business and encourage
stakeholders
How we perceive ourselves as a country for
pharmaceutical business may not correspond
with reality
-
Healthcare system
Correct internal information is as essential
as external communication
Chasm between industry and and academic
research
-
Demonstrate same value is given to all
types of trials
Even distribution of types of trials and
increased flow may give ability to improve
internal routines and infrastructure at sites
Increased communication with health care
personnel
-
Increase interest for conducting clinical
trials by engaging the health care
Investigate the need and incentives in
health care, and how these could be
enhanced
There are changes in attitudes and structure
already progressing, highlight and
communicate these externally as well as
internally.
64
Stage 2- 3
Conclusion
Feasibility
Large Pharma needs simple and fast
information
SME needs support in feasibility
process
Channels
Large Pharma´s local
departments/marketing offices need
arguments
Recommendation & Rational
Create “Copy+paste” presentation material in english
-
International HQ do not have sufficient insight into
specific countries to make informed decisions
SME needs connections and
networks
Increase internal communication and networks for e.g.
trial sites and investigators.
Encourage partaking in international networks
Scientific expertise
Engage scientific expertise in various fields
-
With ability to give input and support smaller
companies in particular.
Support the capacity to refer to additional experts
and/or trial sites
Engage Ambassadors
-
Should hold knowledge of both the clinical and business
aspects of drug development
65
Stage 4
Conclusion
Absorption
Recommendation & Rational
Demonstrate faster absorption of new therapies into the health
care system.
-
Added value
Need to demonstrate an added value to the customer
-
Support and feedback
Benefit patients by gaining access to new and improved
therapies.
Opportunity to place Sweden in forefront, not only in research,
but throughout the whole pharmaceutical value chain.
Not solely about minimizing cost, rather be able to predict a
good trial outcome
Create system for feedback and implementation of changes in
previous stages of the model.
-
Use to validate change and build track record
Engage all active stakeholders, including site personnel in
providing feedback.
66
8.Reflections
On the following pages reflections made by the author in relation to the method and the
results will be presented.
Reflection on method
The main implication for the analysis is that the qualitative data reflects a limited number, 10
of in-depth interviews and the quantitative results is based on a data set of merely 22
respondents. Hence, the ability to generalise the results are limited. Although, the method
used by having qualitative data collection as primary data and quantitative data as a
supportive recourse seems to partly have compensated for this. The results from the two data
collection methods does to the most part point in the same direction, as presented under
section 8, this makes for that a certain level of generalization of the results is still possible.
Therefore, the author is of the opinion that the thesis in large fulfils its aim to understand the
needs and objectives of the industry, to understand what characterises the decision making
process and to identify on what arenas a clinical trials sponsors and/or performer encounter
information on possible trials sites.
A majority of respondents, in both data sets, represents the Large Pharmaceutical industry.
This may lead to an over-representation of this segments in the results and create a
favouritism. Dividing the data and the result into the three different segments is an attempt to
mitigate this risk.
In one question survey participants were asked to consider the importance and rate specific
factors connected to conducting a trial in a certain country, in regards to the Clinical Phase
they were working within. This question was removed from the final result due to
inconclusive answers. The quantitative method, gave a total of 22 answers and a response rate
of 44%. Lowers response rate was for the Large Pharma segment with 38%. As all
correspondence was made via email, which may have had an impact on the responds rate.
Moreover, as selection of target population was made by contacting individuals known to the
author or to the Office for Clinical Studies and further sampling was made via those
individuals or by contacting supplementary companies within the field. This gave for a
limited sampling and limited number of survey responses, on the other hand it gave the author
the ability to make sure relevant targets was reached and also made it possible to control that
the survey reached individuals from all industry segments (Large Pharmaceutical companies,
Small and Medium sized Entities in pharmaceutical and Clinical Research Organisations), to
enable comparison between segments.
67
Reflections on results
In relation to the challenges brought up by respondents during interviews, an additional
interview was made with the Life Science Coordination of Sweden, Anders Lönnberg. The
interview was made as a consultation to get a deeper understanding of how these challenges
has been comprehended on a governmental basis and how they are being undertaken as of
today. This gave the author the ability to put recommendations and reflection in relation to
what is being done today and how the future of Swedish Life Science will be shaped.
Focus of the interview was put on the Swedish health care, as this was a main concern
brought up by all respondent. A lack of incitements within the system, lack of qualified
investigators and personnel was some of the concerns brought up by respondents in the
qualitative study. In regards to the lack in incentives, this is due to two main reasons,
according to Anders Lönnberg. Internally within the county, as many respondents also
commented on, the compensation is paid to the county, not to those who are conducting the
study on site. Moreover, as an individual investigator, you do not earn as much merits by
conduct an industry sponsored trial as you would by conducting an own or academic one.
These factors may create internal incentive hurdles. This matter is, according to Anders
Lönnberg, under assessment. Additionally, is it an external challenge, as the benefits on a
societal level, in terms of less health insurance costs and increased tax revenues etc. falls on
the government. While the cost of care falls on the county. Consequently, there is need to
accomplish both individual incentives as structural incentives to increase engagement from
the health care. Changes in these regards are, according Anders Lönnberg under construction.
Which is partly achieved by increased collaboration between academia, industry and health
care. According to Lönnberg is there a growing understanding within the Swedish health care
to no longer “be regarded as a merely consumer, but must also itself be a producer of
evidence” (Lönnberg, 2016). Evidently, there is a need to communicate these changes in
attitude and structure towards trial sponsors and/or performers.
In relation to these comments and to the results of the data collection some approaches for
marketing and communication seem more advantageous in the shorter term. It is evident from
the result that the primary challenge is not attracting an increased amount of clinical trials, but
rather be able to attain and retain the requests that Sweden already becomes. There are two
means by which this is most likely achieved.
68
Internal marketing, aiming towards increasing the incentives for the health care and to keep
clinical trials top-of-mind. From the results it is apparent that lack of time, recourses and
incentives to conduct clinical trials within the Swedish heath care is as a major hurdle.
Although, this issue has started to gain attention, additional efforts are needed. Efforts made,
changes in attitudes and structure already in progress needs to be highlighted and
communicate externally as well as internally. To demonstrate and communicate efforts made
in this area would be advantageous from a marketing perspective, as it manifests the actions
Sweden has taken to coordinate and support clinical trials in the country. Further, encourage
collaboration between industry, academia and healthcare. It is evident that an increased cooperation between these entities is a necessity for retaining and attracting clinical trials
activities to Sweden. As noted in the result, an increased collaboration between these entities
would possibly result in better quality for all types of trials. It is suggested that clinics with an
evenly distributed flow of trials, from both industry and academia may have a better outcome.
Although, further research on this matter is needed.
Secondly, to achieve the most impact in communicating Sweden as an attractive county for
clinical trials towards industry trial actors and to attain sponsors from the large pharma
segment. It is evident that decisions are steered by fulfilment of specific criteria’s in terms of
ability to find patients, time etc. If these criteria’s or “hard metrics” are met, decision on final
trial locations are made on a high level, at the global head offices. It is not likely decision
makers have sufficient insight into specific countries to make fully informed decisions.
Therefore, communication and marketing of Sweden must be made internally, within the
company. Hence, there is a need to support the local/regional offices in this process. In the
short term this support may be in creating presentation material entailing arguments and facts,
for the local offices to utilize.
In a longer perspective, branding of Sweden is essential, by empathize excellence in research,
increase academic publications and utilize story telling/case studies in communication.
Particularly important is to profile and differentiate Sweden, as several countries are
undertaking similar investments in clinical trials. There is a need to identify where Sweden is
unique and can excel. This should be made in relation to the changed pharmaceutical
landscape, where new kinds of business models, an increased focus on prediction of outcomes
and implementation of technology and big data solutions is apparent. There is a need to be
proactive and demonstrate adaptability in this area, as it is evident that both the internal and
external image of Sweden as country for clinical trials may not be up to date.
69
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Appendix 1. Framework of questions
Introduction- Aim of study
The primary objective of this study is to:
o
To define how a common country selection strategy used by industry clinical trials sponsors and/or
performers can be described.
o
To understand what characterises the internal decision making process when a clinical trials sponsor
and/or performer selects where to locate a study.
o
To identify by what external channels a clinical trials sponsor and/or performer encounter information
on possible locations to perform a study.
The data collected will be used to construct proposals for what should be communicated, as
well as how and where Sweden should be promoted as an attractive country for performing
quality trials, in order to make Sweden more attractive for industry clinical trials.
The result will be presented anonymously.
Background information
How would you categorize your organization?
-
Large Pharmaceutical company
Small/medium sized Pharmaceutical company
Medical Technology company
Clinical Research organization (CRO)
Academic Research Organization (ARO)
Industry organization
Other
What is your title/role in the organization? Describe where you work.
Country selection strategies
What approach is used for trial country selection in your organization?
What, would you say, are the main factors determining where you locate a study?
Which factors/ features do you consider success factors? E.g. What is most important to
guarantee a successful trial.
To your knowledge, have your organization ever done, or considered to do a trial in Sweden?
If your organization would consider Sweden as country to set up a clinical trial.
- What do you believe would be the determining factors for choosing Sweden?
- Or not choosing Sweden as country? What would effect this?
Decision making process
Would you say the activities leading up to a decision are made in a structured way?
Does this involve several steps? Please describe these sequentially.
Example of sequential decision making process:
75
ACTION
PERFORMER
Order of feasibility study
Clinical department (Sponsor)
Suggestion who should be country coordinator or PI
Market department (Sponsor)
Appointing of monitor to collect information
CRO
Conduction of feasibility interviews
Monitor
Decision on which centres to suggest
CRO Manager
Acceptance or rejection of suggestions
Sponsor
Framework adapted from: Demeter, J. (2002). Selecting sites and investigators. Applied Clinical Trials,11(3), 5666.2002.
By whom is the final decision taken where to locate a study?
E.g. :
Decision on location is made by the head of the department, after consultation.
Decision on location is a committee decision
Decision on location is made by a third party (e.g. a CRO)
Decision on location is not made in a very structured way
Other (please specify)
Who has the ability to impact the decision on trial location? To what extent?
E.g.: Medical affairs, Regulatory affairs, Marketing department, CRO, ARO.
Do you ever find conflicting opinions between these parties?
Information channels
What are the most common arenas and channels for information on study locations?
E.g.:
Direct marketing
Conferences and network meetings
Trough networking and PR
Industry news and papers
Social media
Newsletters
Own marketing department
There is no specific marketing in this area
Other
On what level is the information? E.g. About a Country, a Region, a Specific site, or even a
specific investigator?
76
Are your organization actively searching for information on new study locations, in what
way?
Other
How would you say your organization values:
Social Media as a channel for information
Academic publications as result of a trial
How would you say your organization considers the role of:
Clinical Research organizations (CROs)?
Academic Research Organizations (AROs)?
Key Opinion Leaders?
National and/or international networks such as the Nordic Trial Alliance or similar?
Do you have any other reflections on the topic?
77