taking
part in clinical drug trials
A
Patient Guide
What
is a clinical drug trial?
A
clinical drug trial is a carefully controlled study in which
patients take a drug to find out whether it is safe and effective
and the optimal dosage.
In a clinical
trial, one or more different drugs or combinations of drugs
are compared to each other. A clinical trial often gives one
group of patients an experimental drug, while the other group
gets a placebo (“Sugar tablet / capsule”).
Who
can join a clinical drug trial?
Each clinical drug trial has strict guidelines and criteria
to help in the selection of candidates for each study, e.g.
age, previous and recent medical and psychiatric histories,
prior and concomitant treatments, and pregnancy.
The criteria differs from study to study and enrolling into
a study is voluntary.
Reasons
to join a clinical trial or not
Deciding to join a trial can be difficult. There are always
risks involved taking any medication. Carefully weigh the risks
and benefits of a trial you are considering to join.
Reasons
to join a trial
- the
treatment being tested may work for you
- clinical
drug trials may be the only way to gain access to a promising
new drug
- drugs
that are given in a trial are free
- you
can help speed the development of new treatment
- your
contributions of information, while in a clinical drug trial
may benefit others
- you
will be one of a small percentage of the population to receive
this treatment
Reasons
not to join a trial
- you
may have to stop taking your current medication that works
for you
- your
condition may get worse
- the
treatment in the trial may have unexpected side-effects
- you
don’t have the energy, time or interest to participate
in a trial
What
is informed consent?
Informed
consent is a document designed to inform you of the purpose
and design of a study, its possible side-effects and benefits
and what your other options may be. It is required by the Food
and Drug Administration in America, the Medical Control Council
of South Africa, as well as the Ethics Committee of your local
drug trial unit. The consent form is not a contract. You can
leave the trial at any time, without giving a reason.
What
do I need to know or do before joining a clinical trial?
Every
trial is different, so it is important to familiarise yourself
with all the aspects of the study, before joining it. Everything
regarding the study should be explained to you by the Doctor
or Specialist (Investigator) conducting the study. You must
get the opportunity to ask questions and should be provided
with understandable explanations before signing any consent
form.
What
about my medical needs while participating in a trial?
While
you are participating in a clinical drug trial the investigator
of the study will do regular physical examinations, special
investigations and laboratory tests. If he or she is concerned
about anything they will refer you to a specialist or a general
practitioner to investigate your problem. If this problem occurred
while you’re in the study and the investigator feels it
may be drug related, the sponsoring company may be responsible
for any costs.
When joining a study your investigator should inform your general
practitioner or specialist about the study.
My
rights as a patient
- To be
informed of the nature and purpose of the study.
- To be
told what will happen and whether any of the procedures, drugs
or devices are different from what would be used in standard
practice.
- To be
told of the discomforts and / or the risks that can be expected
from the study.
- To be
told of the benefits to expect while participating.
- To be
offered other options apart from participating in the study,
the benefits and risks of alternative options should be explained.
- To be
allowed to ask any questions concerning the study before entering,
while in the study and after completion.
- To be
informed what concomitant treatment is available to treat
any side-effects.
- To be
able to refuse to participate at all or to stop participating
after the study started and that this decision will not affect
rights to receive medical care outside the clinical trial.
- To receive
a copy of the informed consent.
- To be
under no obligation or pressure while deciding, before agreement
to participate in a trial.
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