The value of medical research data
sharing and re-use
A multi-stakeholder discussion at the
EU Parliament organised by the
eTRIKS project.
European Union Parliament
Brussels
20 October 2016
Table of contents
3
Executive summary
5
eTRIKS: a sustainable translational research informatics platform
6
Data re-use, a valuable resource
10
eTRIKS Play Decide Event
11
eTRIKS Play Decide Event Results
14
Survey: Where can synergies be built?
15
Concluding remarks
16
Appendix
16 The eTRIKS Play Decide game
17 Game board
18 Survey results
Executive Summary
On the 20th of October 2016, eTRIKS, led by
BioSci Consulting together with the IMI
organised
a
multi-stakeholder
event
“eTRIKS Play Decide”. The main aim of the
event was to outline the steps needed to
promote the re-use of medical research data.
With the growing importance of technology
and big data, different perspectives exist on
the sharing and re-use of data. For example,
patients are usually concerned with their
data privacy while data owners’ issues rise
from a sensitivity to share research data.
The structured discussion therefore aimed to
open a dialogue and reconcile perspectives,
looking at how to build synergies. In a bid to
do this, eTRIKS used the multi-stakeholder
discussion ‘Play Decide’ game, a EU funded
platform that stimulates the use of discussion
games and other debate formats.
The event gathered a large number of
patients, researchers and policymakers
together as well as members of the European Parliament and Philippe De Backer,
Belgium Secretary of State for Social Fraud
and Privacy.
The discussions allowed participants to
share viewpoints and discuss challenges,
particularly on data protection and privacy as
well as data sharing. Although a number of
clear messages came out of the discussion
and shared group response sessions, there
were four areas that were particularly salient.
On the one hand, participants were worried
of the insufficient safeguards and guarantees
against nefarious data uses. They believed
that there is still a need to build trust in data
reuse and build meaningful relations
amongst stakeholders. Further, there should
be more awareness on what data sharing
means.
The success of this event also showed that
understanding other perspectives and looking to where there can be synergy as
opposed to compromise can lead to creative
solutions and real progress on challenging
issues such as the sharing and re-use of
medical research data.
3
We all tend to view problems only from our own perspective.
Understanding other perspectives and looking to where there can be
synergy as opposed to compromise can lead to creative solutions and
real progress on challenging issues such as the sharing and re-use of
medical research data.
Structured discussions like the one held at the European Parliament
with multiple stakeholders are always enlightening. The discussion
game event was meant to have an open and meaningful dialogue to
gain a better understanding in regards to the sharing and re-use of
medical research data.
If we are to realise the promise of personalised medicine larger datasets are needed to have a better understanding of the differences
between individuals with the same disease.
“In addition, the data that we can now generate with new technology
is detailed enough that the value of any given dataset extends beyond
the research question for which it was originally collected.
- Scott Wagers
Physician scientist and chief executive of BioSci Consulting
4
eTRIKS: a sustainable translational research
informatics platform
The European Translational Research Information and Knowledge management Services (eTRIKS) consortium is an Innovative
Medicines Initiative (IMI) platform that supports projects – typically multi-stakeholder
research collaborations – with the integration, analysis, and preservation of their translational research data.
The growing interest on big data and technology has meant that the re-use of data for
medical purposes faces new challenges,
including issues on data protection or data
sharing. In a bid to understand perspectives
and challenges and to help reconcile positions, eTRIKS is using the multi-stakeholder
discussion ‘Play Decide’ game.
As seen in Figure 1, eTRIKS allows participating projects to make the most of their data
so that they can enhance their efforts to
enable precision medicine. One of the central value propositions for eTRIKS is seen to
be enabling data re-use.
This will not only help increase awareness on
re-use of medical research data in Europe
but also contribute to on-going debates on
data protection, sharing and integration of
data.
>50
Multi-stakeholder research collaborations supported
12
Open Source tools that increase the value of data
350
Researchers trained in eTRIKS technology
58
Publically available data sets
2
1 spinout (ITTM) and 1 ELIXIR Node
Figure 1: eTRIKS metrics indicate how the consortium enables precision medicine
5
Data re-use, a valuable resource
If we don’t share data we are not going to get the advances in
medicine we so desperately need.
We will only see real progress by increasing our range of knowledge
and more data will help with this – but there is a public perception that
giving out data puts you at risk. We need to change that mindset and
develop greater trust, otherwise people are simply not helping themselves to help others.
There is a growing demand for personalised medicines but to get the
specific information you need to tailor a drug you have to be able to
tap into a wider pool of shared datasets to have a better understanding of the differences between individuals with the same disease.
- Val Hudson
Patient representative for Asthma UK on the U-BIOPRED Ethics
Board. A passionate advocate for sharing clinical data and the
advancement of personalised medicine.
The re-use of medical research data is a
controversial issue. Not least because there
exists a number of different perspectives on
the issue, but many of the challenges that
arise are difficult to solve.
Currently, most of the advice given to
patients is based on medical opinion and not
data. However, the growing wealth of medical research in the advent of mobile health
platforms and big data provides us with a
unique opportunity to use technology to our
advantage and strive for precision medicine.
In this context, there is an increased interest
in the sharing and re-use of medical
research data to make healthcare more
innovative and efficient. Technological developments have also allowed us to generate
datasets that extend beyond the research
question for which they were originally
collected.
So, a key opportunity lies in the better use of
existing datasets and re-use of medical
research data to enable improved medical
research and therapeutic outcomes.
6
There are two main stakeholder perspectives that transpire from the challenges
created by the re-use of data. Firstly,
patients or people whose data is being
shared tend to be concerned with data privacy and protection and the purpose of the
shared data.
Often, patients have a desire to share their
data, to help medical progress, but they are
put off because they do not know how safely
their data will be handled. Moreover, the
re-use of research data usually involves data
that was collected for a different purpose
making it less clear to assess the value of
the data provided.
Secondly, many data owners, usually medical researchers in academia or industry partners, are unwilling to share their data. Extensive effort goes into a clinical study and the
analysis of the data can take many years.
The sensitivities around publishing findings
are one reason why many researchers adopt
a conservative approach to sharing their
data.
Only by considering the different perspectives on re-using medical research data can
synergies, essential for collaboration in the
development of treatments, be created.
Ensuring participation allows an understanding of different perspectives, which if properly facilitated, should lead to more effective
policy formation and implementation (Figure
2).
Successful multi-stakeholder engagements
therefore should focus on building trust,
participation, education and confidence.
Through its work, eTRIKS is striving to
bridge the gap between the different
perspectives by raising awareness and
allowing participants to reach synergies
between their perspectives.
©BioSci Consulting
Figure 2: Share medical research data based on trust and cooperation will maximize the output and synergy.
7
In discussing approaches to sharing data it is important to bear in mind why we would want
to share and re-use medical research data after the initial studies are complete. A selection
of the key reasons to re-use medical research data are:
To speed up the development of new drugs and treatment
To assess current medical therapies with view to improving these therapies
To speed up the new therapy development process
To move towards precisions medicine, enabling doctors to make the right choice
of treatment for an individuals
To provide evidence that could inform decision makers of the importance of the
disease and of a line of investigation
To gain valuable insights into an individual’s condition. The breadth of patient
specific in data research far outweighs the traditional scope of clinical assessment
To generate and investigate new hypotheses. The re-use of data broadens the
scope of effective use of data meaning it can also be used
To enable health economics research on effectiveness of treatments
To enable patients to take control of decisions
To shed light on a variety of diseases broadening the scope of the patient and
societal benefit
It must not be forgotten that medical
research is an iterative process with new
hypotheses, or questions arising from studies. Yet data is often collected under an
informed consent with one very specific
purpose, often either restricting the further
use of the data or making it unclear what the
data may be used for. While researchers see
a lot of potential value in re-using existing
datasets this needs to be balanced against
the protection of privacy, which means some
guarantees are needed alongside improved
definitions on the use of the data when
informed consent is made.
8
Equally, understanding the risks in data
sharing and around anonymisation involves
clear and explicit communication that in
many cases is not effectively carried out.
Study participants may favour being protective of their data privacy with regard to medi-
cal research data re-use due to both legitimate concerns around data privacy but also
due to a lack of communication around and
therefore understanding of what happens to
their data.
I think we need an open and transparent debate on medical
research data. It’s important to get it right. If you lose trust in the
system then you risk a 10 or 20 year backlash.
Patients are understandably concerned that handing over data come
back to haunt them and more needs to be done to reassure people
that it will not be used against them when it comes to future employment, stopping you getting a mortgage or inflating your insurance premiums.
One of the major issues is when there are research questions you did
not know you needed to ask when the data was collected.
“Researchers see potential value in re-using existing datasets but that
needs to be balanced against the protection of privacy.
- Philippe De Backer
Belgian Secretary of State for Data Privacy, social fraud
and the North Sea
9
eTRIKS Play Decide event
Together with the IMI, eTRIKS, led by partner BioSci Consulting, organised the
multi-stakeholder discussion event “eTRIKS
Play Decide” at the European Parliament in
Brussels on 20th October 2016. The participatory format brought patients, researchers
and policymakers together with members of
the European Parliament and Philippe De
Backer, Belgium Secretary of State for
Social Fraud and Privacy. The broad range
of stakeholders who participated in the event
is illustrated in Figure 3.
The main aim of the event was to further
outline what steps were needed to develop
the re-use of medical research data. Based
on previous multi-stakeholder discussions,
and as explained above, “eTRIKS Play
Decide” took into account the different
perspectives on data re-use and tried to built
synergies not only to achieve greater results
in medical research but also to allow for
stakeholders to make better informed decisions about data.
©BioSci Consulting
Figure 3: Multi-stakeholder participation in the eTRIKS Play Decide event.
The icon depicts the number of representatives of each stakeholder type.
10
Built into the event was the aim to enable
patients, as well as other stakeholders, to
make well-informed decisions on their data.
The participants focused on how the different decisions on the use and re-use of medical research data impact each step of the
data value chain, as shown in Figure 4. This
prompted a discussion around the area of
awareness in the value chain and special
emphasis was given to improving information from the contact points in clinical trials,
typically clinicians and research nurses.
©BioSci Consulting
Figure 4: A representative image of the thematic of the event that will help to inform
each individual stakeholder on the multiple aspects of the medical data value chain.
eTRIKS Play Decide results
Although a number of clear messages came
out of the discussion and shared group
response sessions, there were four areas
that were particularly salient, as shown in
Figure 5. Alongside the synergies, different
viewpoints were expressed in each discussion. Participants were mostly concerned
with the insufficient safeguards and guarantees against nefarious data uses. Participants believed that there is a need for the
research community to improve education
on building assurances and increase awareness on issues, especially the value of medi-
cal research data, to enable truly informed
consent.
Further, participants agreed that there is a
need to build trust in data and in the use of
that data, underscoring the importance of
cooperation and trust as reflected in Figure 2
(Page 4). Additionally, greater efforts are
needed to build bridges across stakeholders
by improving information and awareness
between translational researchers and
patients, as well as between patients and
policymakers.
11
A number of important points can be highlighted from the discussion:
Trust bulding among stakeholders is needed
Societal debate needed to bridge the gap between perspectives
Use of medical research data
for nefarious purposes such as
denying insurance should be
made illegal
Data standards are fundamental in ensuring both quality and
re-usable data is produced
We need to move towards ‘true’
informed consent
It is important to not confuse the
general privacy discussion with
the medical research data
debate
Involvement in a research study
should be a transactioal educational process
We have to determine how
further awareness is built
Degree of redundancy in medical data that is collected as
many studies limited in scope
and scale require large datasets
Clinicians and nurses may lack awareness on how to communicate
12
Figure 5: Summary of the different table discussion with a synergistic viewpoint per table. We identified
four areas thought to be of greatest importance, which are shown in the four quarters of the diamond.
We want to create a new culture of openness in research,
making the sharing of data much easier and opening up more opportunities to pursue medical advances.
However, in order to support our new smarter approach to research,
we also need a new culture where research participants and the general public are informed and are part of the solution.
- Paul Houston
Research standards expert and head of operations for
CDISC Europe Foundation, a not-for-profit organisation campaigning for standards in research data.
13
Survey: Where can synergies be built?
A short survey was carried out at the end of
the event, to provide a score for the four
positions the participants felt they could take
regarding the subject matter of the discussion.
These four positions are seen in Figure 6.
Perhaps because it was a qualified statement (‘adequate protection of research
data’, in some instances), position three met
with the agreement from all participants.
Considerable support was given to position
‘compulsory to share research data’, but this
was balanced against the support for positions one and two, which oppose this standpoint. In spite of being a convergence to
some opinions and approaches to the issues
raised, considerable differing opinions in the
room still exist. A way to develop a policy
position is to form synergies from these positions. Further survey results can be found in
Appendix 3.
3
100%
4
80%
60%
40%
Support
2
1
20%
Acceptable
-20%
-40%
-60%
-80%
Not acceptable
-100%
Support +
Not acceptable -
Support ++
Not acceptable - -
Support +++
Not acceptable - - -
data should only be used in the project
1 Research
that the individual originally consented to.
own their research data, trust them to share.
2 Individuals
New uses of research data should require re-consent.
some instances research data can be shared when
3 Inthere
is adequate protecion of personal data
4 It should be compulsory to share all research data
Figure 6: Results of the survey associated with the Discussion game at the end of the event.
14
Concluding remarks
From the discussions, it emerged that all the
different perspectives that currently exist
should be accounted for if consensus is to
develop in the field. However, before this is
possible education has to have a stronger
role in creating a more informed stakeholder
landscape, enabling study participants to
agree to ‘true’ informed consent and allowing
medical researchers to better understand
the wider issues around data sharing and to
communicate better with study participants.
Policymakers do consider protecting the
public as a priority. However increasing
awareness of the current challenges and
opportunities related to the reuse of medical
research data may facilitate more structured
policy making, targeted at ensuring that both
data privacy is respected and that impetus is
built into the policy framework to ensure the
value in medical research data is exploited.
The eventual aim is to allow more efficient
drug development and healthcare responses. The solution relies in building up trust
There are also broadand
cooperation
er issues around acabetween
different
demic
researchers
stakeholders
as
repreNext actions
and clinicians being
sented in Figure 2.
Promotion of the version of
more open to sharing
Play Decide on the Play
medical
research
The next steps for
Decide
website
and
upload
data.
Researchers
eTRIKS are to take the
of further results
who have invested
learning from this event
(http://www.playdecide.eu)
heavily in producing
into a further developdata often want to
mental
cycle.
The
Hosting online conference
protect the value of
version of the open
call
versions
of
the
game
their efforts, but this
source game “Play
(https://www.etriks.org/discan occur beyond
Decide’ used in this
cussion-game/)
necessary time perievent has been updatods. Equally, innovaed on the Play Decide
Support further “eTRIKS
tion requires more
website
(http://wwPlay
Decide”
events
in
openness in data
w.playdecide.eu). The
response to demand seen to
sharing, to leverage
game can be downloaddate
the existing data by
ed and people may
enhancing access to
organise their own sesthis data.
sions. Hosting of online
conference call versions of the game
While study participants and patients rightly
(https://www.etriks.org/discussion-game/) is
have concerns around their privacy relating
in planning. The major action to develop the
to data sharing, an awareness of how mediresults into outputs will see a further play
cal research operates and what occurs when
decide process run alongside the eTRIKS
data is shared will allow much more informed
Assembly General Meeting and Translationperspectives to be developed. It may well be
al Researchers meeting in May 2017 in Barthat an individual does not change their posicelona. We also expect additional sessions
tion on sharing their data, and this may be for
to be organized as a result of the interest
good reasons, but the understanding allowgenerated by this event. The results of this
ing an informed decision to be made is
event and all other sessions will feed into the
fundamental and is currently seen to be
session in May from which outputs will be
missing in the research landscape.
produced.
15
Appendices
The eTRIKS Play Decide game
The “eTRIKS Play Decide” multi-stakeholder
discussion game event uses open and
meaningful dialogue to:
1) gain a better understanding of
sharing and re-using of medical research
data
2) to identify areas where there is a need for
action and
3) develop a synergistic viewpoint that can
lead to benefits for all stakeholders.
Different stakeholders have different
perspectives on the balance between sharing data and data protection. Equally different perspectives on the sharing and re-use
of medical research data mean we need to
see a broader societal level of discussion.
By using the interactive discussion session
based on the play decide discussion game
(Figure 7) concrete actions and synergies
can be drawn out of the process of understanding different perspectives from different
stakeholders.
The event consists of individual role cards,
issue topics and information cards that are
used in combination with a game board (Appendix 2).
The game comprises three sections. Firstly,
an information session allows participants to
orientate to the issues and to the game, secondly, a discussion session that brings out
opinions, issues and challenges and lastly a
shared group response, which broadens the
understanding of the different perspectives
and, from which actions are obtained.
Figure 7: Overview of the facilitated discussion game
16
Appendices
Game Board
17
Additional Survey results
18
19