Clinical Trials of
The Food and Drug Administration, or
FDA, is part of the United States government. It is
FDA's job to make sure medical treatments are safe and
effective for people to use.
What is a Clinical Trial?
"Clinical trial" is the scientific
term for a test or study of a drug or medical device
in people. These tests are done to see if the drug or
device is safe and effective for people to use. Doctors
and other health professionals run the tests according
to strict rules set by the Food and Drug Administration
(FDA). FDA sets the rules to make sure that people who
agree to be in the studies are treated as safely as
Why Should Minorities and Women Participate
In Clinical Trials?
In the past, most drug testing has been
done on white men. This means that some groups, such
as African Americans, Hispanic Americans, American Indians,
Asian Americans, and women, have not always been included
in the tests done on drugs. But sometimes drugs work
differently on people in these groups than on white
men. So FDA wants people from many different groups
included in these studies.
Points to Remember
- Clinical trials are tests of medical treatments
to see if they are safe and if they work.
- Before you agree to take part in a study, you
must be given complete information about the study,
including possible side effects and benefits.
- You must sign a special agreement called "Informed
Consent" before taking part in the study.
- You can leave the study at any time.
Informed Consent Protects Volunteers
To help you decide if you want to be a
volunteer in a study, FDA requires that you be given
complete information about the study before you agree
to take part. This is known as informed consent. FDA
requires that volunteers be told:
- that the study involves research of an unproven
drug or device
- the purpose of the research
how long the study is expected to
what will go on in the study and
which parts of the study are experimental
possible risks or discomforts
other procedures or treatments that
you might want to consider instead of the treatment
that FDA may inspect study records,
but the records will be kept confidential
whether any medical treatments are
available if you are hurt, what those treatments
are, where they can be found, and who will pay for
the person to contact with questions
about the study, your rights, and injuries related
being in the study is voluntary
and you can quit at any time.
Informed consent information should be
written so you can understand it. If you don't, be sure
to ask the doctor or other medical person to explain
it. Make sure you understand all of it before you agree
to be in the study.
Before you can participate in the trial,
you must sign the informed consent form, showing that
you have been given this information and understand
it. The informed consent form is NOT a contract
and you can leave the study at any time, for any reason.
Other Ways Volunteers Are Protected
- Institutional Review Boards (IRBs) --
Scientists, doctors and other people from the local
community serve on IRBs to review and monitor their
hospital's or research institution's medical research
involving people. They monitor studies to help make
sure that there is the least possible risk to volunteers
and that the risks are reasonable in relation to
the expected benefits. IRBs make sure volunteer
selection is fair and that informed consent is done
Data Monitoring Committees -- These
committees are used mainly when one treatment is
being compared with another and in studies where
treatments are selected for patients at random.
These committees are particularly important in tests
of treatments for serious or life-threatening disease.
These experts review information from studies to
make sure they are being done in a way that is safest
for the volunteers. During a study, if the committee
finds that the treatment is harmful or of no benefit,
it will stop the study. If there is evidence that
one treatment gives a greater benefit than another,
the committee stops the study and all volunteers
are offered the better treatment.
FDA Inspections -- FDA inspects
records and various scientists, clinics, and other
research sites involved in a study. To make sure
volunteers are being protected and studies are being
done correctly, from time to time such inspections
are done in response to complaints.
By taking part in a clinical trial, you
can try a new treatment that may or may not be better
than those already available. You can also contribute
to better understanding of how the treatment works in
people of different ethnic backgrounds and genders.
What Are the Risks?
Many studies require that neither
the patient nor the doctor know whether the patient
is receiving the experimental treatment, the standard
treatment or a placebo (an inactive substance that looks
like the drug being tested). In other words, some volunteers
may be getting no treatment at all.
Some treatments that are being tested
have side effects that can be unpleasant, serious or
even life-threatening. Because the treatments being
studied are new, doctors don't always know what the
side effects will be. Many side effects are temporary
and go away when the treatment is stopped. But others
can be permanent. Some side effects appear during treatment,
while others may not show up until after the treatment
is over. The risks depend on the treatment being studied
and should be fully explained to you in the informed
Questions to Ask
Here are some questions to ask your doctor
to help you decide if you want to take part in a clinical
- What is the study trying to find out?
- What kinds of test and exams will I have to take
while I'm in the study? How much time do these take?
What is involved in each test?
- How often does the study require me to go to the
doctor or clinic?
- Will I be hospitalized? If so, how often and for
- What are the costs to me? Will my health insurance
pay for it?
- What follow-up will there be?
- What will happen at the end of the study?
- What are my other treatment choices? How do they
compare with the treatment being studied?
- What side effects can I expect from the treatment
being tested? How do they compare with side effects
of standard treatment? How long will the study last?