clinical research
participant
information
clinical research participant information | 01
“…you are playing
a part in the
advancement of
medical knowledge
and in bringing
new medicines
to people who
need them.”
Professor Garry Jennings AO
welcome to the centre
for clinical studies,
a division of nucleus
network
Nucleus Network is a not-for-profit clinical research and
education company that is wholly owned by the Baker
Medical Research Institute. Clinical research is a crucial
part of bringing new medicines to the community. Every
new medicine that you or your family have ever taken
has undergone stringent clinical testing to ensure that
the medicine is safe and effective.
The clinical trials performed at Nucleus Network involve
either healthy volunteers or patients with specific medical
conditions. The types of medicines that are tested at
Nucleus Network are extremely varied but are generally
in the early stages of clinical development (phase I).
Healthy volunteers are often involved in the earliest
research because they are healthy and their bodies
are ‘fully fit’ to absorb and process the new medicine.
Patients may also be involved in the earliest studies,
this is often the case when the new medicine being
researched will only have an effect on patients with
a specific disease. All clinical trials at NN are carried
out according to the National Statement on Ethical
Conduct in Human Research (2007) produced by
the National Health and Medical Research Council
of Australia.
Whether you are a healthy volunteer or a patient
participating in a clinical research trial, you are playing
a part in the advancement of medical knowledge and
in bringing new medicines to people who need them.
Thank you for your participation.
Professor Garry Jennings AO
02
clinical research participant information | 03
what is clinical research
of medicines?
Clinical research is the testing of new medicines on people, after it has been
through pre-clinical testing. Clinical research of new medicines has three
main phases:
Clinical research of new medicines
is the testing of them on people.
Every new medicine must undergo
detailed clinical testing before it can
be registered and made available
to the community.
phase I
Initial testing of the safety, tolerability and absorption of the new medicine. Phase
I studies often involve healthy volunteers and start with very low doses. Typical
Phase I studies may involve giving a single dose of the new medicine followed by
repeated blood samples to see how long the new medicine stays in your body.
A new medicine takes 5–10 years to develop. After the discovery of a new
medicine the initial testing will be done in laboratories using specialised ‘ex-vivo’
tests (tests in animal tissues but not in living animals or humans). The next phase
of testing is ‘pre-clinical’ – meaning in living animals. These animal tests are
regulated by an Animal Ethics Committee to ensure that the tests are appropriate
and ethical. Animal testing is required on all new medicines before they can
be tested on people.
Once a single dose study is completed, multiple dose studies are undertaken
to see how long the new medicine stays in the blood after repeated dosing.
These types of studies are what ultimately lead to the ‘prescribing information’
for a new medicine. For example if a medicine says “take 2 tablets twice per
day, morning and night” this has been determined from the studies that have
measured how long it takes for the medicine to leave the body system.
Other phase I studies may include testing for interaction with other medicines
and food. For example if a medicine’s ‘prescribing information’ says “take on
an empty stomach” or “not to be taken with heart medications”, this is because
the clinical tests have shown that the medicines are affected by eating food or
by taking another medication at the same time. Understanding interactions
with other medications is particularly important because many people may
be on multiple medications at the one time.
Phase I studies usually involve one or more overnight stays in the clinical research
centre to ensure that each participant is subject to the same conditions (food,
clinical tests, exclusion of other drugs – alcohol, caffeine, recreational drugs) and
that they are observed for any adverse effects. Each clinical test is taken at specific
time points in order to record the effects of the medicine over time. In most studies
some participants receive the new medicine and some others receive a similarlooking inactive dummy medicine, called a ‘placebo’. As a participant you will
not know whether you have had the new medicine or the placebo. There are
usually only 10–40 participants in a study.
The majority of the clinical research trials done at the Centre for Clinical Studies
are Phase I trials.
04
phase II
These trials are conducted in patients who have the disease that the new
medicine is trying to treat. The aim of these trials is to test the safety and
effectiveness of the new medicine in the ‘target population’. Generally these
trials will involve multiple doses of the medication and are often carried out on
out patients rather than in hospital. Phase II studies may also require overnight
stays in the clinical research centre to undertake blood tests to measure how
long the medicine lasts in the blood of patients. In certain diseases, such
as cancer, a very successful trial in phase II can allow for the drug to be submitted
for registration. There are usually between 20–100 patients involved in a phase
II study.
phase III
These trials are conducted in patients and may involve hundreds or thousands
of participants. These are called registration trials. In general a new medicine
needs to show that it is safe and effective in two independently-run trials before
it can be submitted for approval by a health authority.
the macfarlane burnet building and baker heart research institute
“my father has
the condition
that was being
researched.”
clinical research participant
the alfred precinct site:
a dedicated clinical trial facility
for world-class clinical research
Located adjacent to a tertiary teaching
hospital within a medical research
precinct. There are 5 research institutes
on site and between 2000 and 3000
medical professionals and researchers
on this precinct.
5th Floor, Burnet Tower,
AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia 3004
the austin hospital site:
a dedicated clinical trial facility
for world-class clinical research
Located within the precinct of Austin Health, a major
provider of tertiary health services, health professional
education and research in the northeast of Melbourne.
This site has a world-renowned reputation for research
and specialist work in cancer, liver transplantation, spinal
cord injuries, neurology, endocrinology, mental health
and rehabilitation.
Austin Centre for Clinical Studies
Level 9
Harold Stokes Building
Austin Hospital
Burgundy Street
Heidelberg
clinical research participant information | 09
frequently
asked
questions
why is it important to be a volunteer?
Every new medicine must go through clinical trials. Without healthy and patient
volunteers, no new medicines would be available to the community. Your
participation today could lead to the availability of a life-saving medicine
for somebody in the future. Every medicine that you have ever taken has been
through similar testing somewhere in the world.
what are the risks?
All clinical research has some level of risk. In order to minimise the risks an
evaluation of the research study is undertaken before it is approved to commence
by an independent Human Research Ethics Committee (HREC). The HREC has
a scientific sub-committee that reviews the science behind the new medicine,
the effects seen in animal studies, the proposed doses to be administered and
the design of the study. The HREC will also often seek further external expert
reviews of particularly novel medicines. The HREC will also review and approve
a Participant Informed Consent Form (PICF)). This is a non-technical description
of the research study so that you can make an informed judgement as to whether
to participate. You should review the PICF carefully. The PICF gives a detailed
description about this investigational study, which the study doctor and/or his
representative will discuss with you. Its purpose is to explain to you as openly
and clearly as possible all the procedures involved in this study, before you decide
whether or not to take part in it. Should you decide to participate in the study,
you will be asked to sign this consent form, and a copy of the signed informed
consent form will be given to you to keep. Every study is different in its risks,
design and its duration.
As a participant in a clinical research study you will be constantly monitored
by qualified staff including doctors, nurses, pharmacists and allied health
professionals.
10
what will happen during the
screening process?
If you have expressed interest in a
particular study, you will be telephone
pre-screened by one of our recruitment
staff. The telephone pre-screening will
provide you with high level information
about a particular study and you will
be asked a number of general questions
about your health, medical history and
availability. If you appear to fit the
general criteria (e.g. body weight,
height, smoking status, medical
history etc.) you may be invited
to attend a screening visit.
At or before the screening visit you
will be supplied with a copy of the
Patient Information Consent Form
(PICF). Before agreeing to participate
in this study, it is important that you
read and understand the PICF which
provides the explanation of the study
and its procedures. The PICF describes
the purpose, procedures, benefits,
risks, and discomforts of the study.
You should consider discussing your
participation with family, friends or your
local GP. For your own protection it is
important that you reveal your entire
medical history. Giving false, incomplete
or misleading information concerning
previous or present medical problems
could be dangerous to your health. If
you choose to participate, you have
the right to withdraw from the study
at any time.
clinical research participant information | 11
The study doctor and/or study
representative will explain any difficult
concepts or words included in the
PICF and answer any questions you
may have about this study. Once you
have signed the consent form you will
undergo physical examination, have
some blood and urine tests and any
study-specific screening tests. The
screening tests may include tests
for recreational drugs. The screening
process will generally take 1–2 hours,
it will then usually take one to two days
to receive blood test results. If your
results come back as suitable for the
trial you may be offered a place in
the trial. Not every participant who
is screened will be suitable to be
offered a place in a study.
It is important that you understand
that your participation in this trial is
voluntary, as is the case with all research
projects in Australia. If you do not wish
to take part in the study, you are under
no obligation to do so. If you decide
to take part, but later change your
mind, you are free to withdraw from
the study at any stage. However, if
you withdraw your consent, you will
no longer be able to participate in the
study. Your decision whether to take
part or to withdraw will not affect your
routine medical treatment or your
relationship with those treating you
or your (present or future) relationship
with The Centre for Clinical Studies.
what happens during a study?
Generally you will be admitted the day before a study starts. When you arrive you
will undergo a number of tests, possibly including a full screen for recreational
drugs and an alcohol breath test. If you are positive for recreational drugs or
alcohol you will be excluded from the trial. In order to maintain a safe and
secure environment your bag will be searched prior to admission to the clinical
research centre. You will not be allowed to bring recreational drugs, alcohol, food
or chocolate into the facility. You will be assigned a bed and provided with a locker
for your belongings.
On the morning the study commences you will be woken early. You will also
probably have one or more cannulas inserted into your arm. A cannula is a small
plastic tube that is kept in a vein in your arm for up to 24 hours during the time
you are in the clinical research centre in order to take the multiple blood samples
involved in this study. You will receive a dose of the new medicine and then have
a series of tests performed – these may include an ECG (measurement of the
heart), blood pressure, blood samples and other tests. Often these tests will be
repeated at frequent intervals (e.g. every 5–10 minutes). All of the tests will be
described in the informed consent form. You will have to remain in your bed for
at least 4 hours after you have received medication.
You will be advised by the study staff as to when you can leave your bed. Each
study lasts for a different period of time – some participants will stay in the unit for
2 days, others may stay for 2 weeks – the duration of your stay will be described
in the consent form.
what should I bring?
You should bring your own toiletries and light clothes. You should wear enclosed
footwear while in the unit. All of your meals will be provided throughout your stay.
You are also encouraged to bring reading materials, ipods, lap-top computer
etc. for your entertainment. Most beds have individual TVs, we also have an
X-BOX, TV, DVD, internet terminals and a pool and air-hockey table.
what happens after you leave the facility?
Most studies will require you to come back a few days after you leave the facility.
These ‘outpatient’ visits are important to ensure that you have not experienced
any undesired effects after leaving the facility. On your final visit you will be
reimbursed for your time and inconvenience (where applicable).
12
what are the house rules?
We have a number of ‘house rules’
that govern behaviour within the clinical
research centre. These rules are put
in place to protect the safety and
privacy of you, the other participants
and our staff. The house rules govern
items such as visitor policy, general
behaviour and safety procedures.
You will be provided with a copy of
these rules or they can be accessed
on our website.
will it cost me anything?
All of your medical costs as part of the
study will be paid for and you will not
be charged for any tests. The sponsor
of the trial will have agreed to provide
compensation to you for any injury
suffered as a result of your participation
in the research project, in accordance
with the Medicines Australia Guidelines
for compensation for injury resulting from
participating in a company-sponsored
research project. A copy of the Medicines
Australia Guidelines is available to you
from the research staff on request. In
the event that you suffer an injury as
a result of participating in this research
project, hospital care and treatment
will be provided by the public health
service at no extra cost to you.
do I get paid?
The Australian Health Ethics Committee
recognises that it is ethically appropriate
to reimburse participant expenses for
taking part in research. In phase I studies
we believe that it is appropriate to
reimburse for time and inconvenience
based on a schedule agreed by the
Human Research Ethics Committee.
The reimbursement is to cover the
inconvenience of staying in the clinical
research centre and your outpatient
visits. A cheque will be given to you
on your final post-study visit. Should
you withdraw from the study before
the final visit you will receive a partial
payment according to the number of
visits you have attended. Participant
reimbursement compensates for your
time, travel expenses, parking, and
inconvenience. This reimbursement
is not made for undergoing risk nor
is it to compensate you for any loss
of earnings as a result of your
participation.
For later phase studies, where there
is the possibility for participants
to derive health benefits from
participation, reimbursement may be
limited to travel expenses.
nucleus network is a not-for-profit
organisation, where does the
money go?
Nucleus Network currently reinvests
profits in developing further clinical
research capabilities within Australia.
This includes providing subsidised
training in clinical research across
Australia, grant support to young
researchers and development of new
research facilities and laboratories.
tell your friends
We hope that you enjoy participating
in a study at the Centre for Clinical
Studies and feel good about your
contribution to the future health
of the community.
We would ask that you refer your
friends to help us in future studies.
Inquire about volunteering for a trial
Phone 1800 243 733
Email [email protected]
www.nucleusnetwork.com.au
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia 3004
Mailing Address
PO Box 6083 St Kilda Road Central
Melbourne, Victoria, Australia, 8008
Contact Numbers
Headquarters +613 9076 8892 (Melbourne)
Fax +613 9076 8911
Fax +613 9076 8940