PARTICIPATING IN CLINICAL TRIALS
Frequently asked questions
What kind of medication will I have to take?
Clinical trials units
help the world’s leading pharmaceutical companies develop existing and
potential new medicines. Each study is different and volunteers may be asked
to trial an existing medication that requires further testing or they may be
asked to trial a new medication that has not been tested in humans before.
If you decide to put yourself forward for a clinical trial you will be given
a patient information sheet (typically at the screening visit, although this
can be requested before you attend a screening visit) that will give you
detailed information on the medication being tested. This information will
include what the intended use of the medication, the trials that have
already taken place, (if any) and the known potential side effects.
Will I be told everything that is involved in the study?
Yes you will
initially be provided with a patient information sheet (before you attend
the consent visit) that will give you detailed information on the medication
being tested. This information will include what the intended use of the
medication, the trials that have already taken place, (if any) and the known
potential side effects. If you are happy to move forward you will then be
given an opportunity to speak to a doctor working on the study. In this
meeting the doctor will explain the study in detail and you will have an
opportunity to ask any questions you may have. Remember if you are not
satisfied with the information you are provided at the meeting with the
doctor, you do not have to progress this enquiry any further.
Can I drink alcohol?
Usually not for 24 to 48 hours before each
session of a study, and whilst on a study. You may be allowed alcohol
between sessions, but this will be outlined in the protocol and discussed at
the pre-study information session.
What happens at a pre-study medical?
You meet a doctor first who will
answer any questions you may have. You should then be asked to sign a
consent form to give your permission to undergo the screening procedures to
determine if you would be suitable to take part in the study. If you decide
to consent to the screening procedures, the doctor will then ask you about
your medical history and give you a thorough medical examination. You will
then have certain procedures performed, usually urine and blood samples,
blood pressure, height and weight and ECG (Electrocardiogram – a heart
activity tracing). Each study is different, so there may be additional tests
to the above, which may require additional visits and procedures at the
Why do we have to eat at set times?
In studies where you are asked to
stay in a clinical trials unit each person on the same study must eat at the
same time so that consistent results regarding absorption of the drug from
your “stomach” are obtained. The timepoints are set by the pharmaceutical
company sponsor and must be adhered to. In some studies, you are not required
to be resident in the clinical trials unit for the duration of the clinical
trial and therefore it is harder to control what volunteers eat and when.
However, if you take part in a study that does not require you to be resident
in the clinical trials unit for the duration of the clinical trial there
will eb certain foods and drinks you will be asked to avoid until you have
completed the clinical trial. These include eating foods containing poppy
seeds and drinks containing caffeine.
Will the insertion of the small plastic tube (cannula) into my vein
through which you draw blood hurt?
The insertion of the cannula should
not hurt. A cannula can be left in the vein for 24-48hrs and is used to
avoid having to continuously puncture veins to get blood samples on days
where multiple blood samples are required, (PK days). On days where only a
few samples are required, and no cannula has been inserted into the vein, a
member of the clinical team will insert a needle attached to a blood
collection tube only for the duration of the blood collection.
What short or long-term side effects might there be?
is different and will have different side effects affecting different
people. The common short-term side-effects are short term feelings of
sickness, headaches, drowsiness and possibly a slight change in
blood-pressure (feeling faint). Any expected side-effects will be explained
at the pre-study information session with the research physician. Usually,
any side-effects are short-lived and will have disappeared prior to your
post-study medical examination. If you are suffering from a longer lasting
side effect, the clinical trials unit you did the trial with will monitor
your situation until the side effect has resolved or they will refer you to
specialist if this is needed.
Has anyone died or become seriously unwell due to their participation in
Over twenty years ago there were two fatalities. In both
instances the fatalities were a consequence of the volunteers withholding
information of drug/medicine use from the study doctor. More recently in
2006 some volunteers became ill at a clinical trial taking place at a
clinical trials unit within Northwick Park. None of the volunteers affected
died, however some were very ill. Since this case, the regulation regarding
the conduct of clinical trials and those units that can perform clinical
trials has become much stricter. Clinical trial’s units are regularly
assessed by the Medicines and products Healthcare Regulatory Agency, (MHRA)
to ensure they meet the requirements to perform clinical trials. Ensure you
ask if the trials unit you are approaching to do a clinical trial with has
been accredited by the MHRA. Also be honest about your medical history and
recreational / prescribed drug use.
Are all studies reviewed by an Ethics Committee and who are they?
clinical study protocols are reviewed by an Ethics Committee and the
Committee should be entirely independent from the clinical trials unit
conducting the trial for whom you are doing the study. Typically the
advertising of a trial and the patient information sheet will state that the
trial has been approved an independent ethics committee, however if this is
not clear you should ask the doctor when you meet with them to discuss the
study initially. The Committee is responsible for ensuring that the
information provided to you is fair, balanced and accurate and that your
rights as a volunteer are maintained. The Committee should consist of
technical people (including doctors and pharmacists) and non-technical
people such as lawyers and teachers. The mixture of technical and
non-technical people means that both scientific and medical information is
thoroughly reviewed and that the information is put in clear, non-technical
terms for potential volunteers. The Ethics Committee also reviews all
volunteer advertising material.
Will taking part in the study have any effect on an application for
health or life insurance?
There is no evidence that anyone has been
refused cover because of participation in a clinical trial. Different
insurance companies have different rules and should you have concerns you
should discuss this with your insurer.
When can I do my next study?
Usually 3 months after the post-study
medical, although this can be more or less depending on the rules of the
next study you wish to take part in.
Do CROs have a financial interest/share in the companies (sponsors)
? In most cases the clinical trials units will
have no financial interest in sponsors, other than the fees charged for
conducting the study, and these are dependent on the scientific outcome. In
some situations the trials unit will be owned by the pharmaceutical sponsor,
however they will still act impartially.
Will I be paid for taking part in a clinical trial?
The answer is
yes. You will be paid for the time you give up for a clinical trial and this
payment is only for time and NOT linked to risk or inconvenience. You will
be paid for the time you spend with the clinical trials unit and payment is
proportional to the time you spend on a study. For example, you will be paid
a lot more if you take part in a 2-week study with lots of extra visits than
if you take part in a single overnight study. You should not view
participation in clinical trials as equivalent to employment and under no
circumstances should you participate in more than one clinical trial at a
What is a placebo?
A placebo is an inactive, fake, or "dummy"
medication or treatment designed to resemble a drug or treatment and given
in the same way. Any improvement in health that is measured, observed, or
felt after the placebo is given is called the "placebo effect". In clinical
trials, a placebo may be given to one group of participants instead of the
active drug or treatment in order to assess whether the latter is actually
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