Why Volunteer? Clinical Trials of Medical
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 possible.
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
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 take
- what will go on in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
other procedures or treatments that you might want to consider instead
of the treatment being studied
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 treatment
- the person to contact with questions about the study, your rights, and injuries
related to research
- 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
- 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
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 consent material.
Questions to Ask
Here are some questions to ask your doctor to help you decide if you want to
take part in a clinical trial:
- 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 how long?
- 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
- 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?