How do clinical trials work? continued...
After you are accepted by the clinical trial and you give your
consent to take part:
- You will be given a structured program to follow.
will have a schedule of tests, doctor appointments, and treatments.
- You may
be asked to keep a diary of your experience during this time.
Doctors, nurses, social workers, and
other health professionals may be part of your treatment team.
Be sure to carefully follow instructions. If you don't
know what you are supposed to do next, call your doctor. Or call the person
responsible for your trial.
medicine or treatment must go through three phases before it is
approved for use by the U.S. Food and Drug Administration (FDA).
What happens when the clinical trial is finished?
After a clinical trial is completed and the results are studied,
the FDA decides whether to approve continued development of the medicine. If
the medicine that you received remains in development, you may be able to
get more doses as an extension of the study.
results of the clinical trial show that the new medicine or combination of
medicines works much better than standard treatment, the new medicine may
become available to the general public.
team may continue to check on you after your trial is over.
What are the risks?
You should be fully informed about the possible
risks of the trial before you agree to participate.
- Although the purpose of trials is to find new and better treatments, the new treatment may not work as well as
- You may have unpleasant, serious, or
even life-threatening side effects from the treatment.
treatment may not work for you.
- The trial may require more of your
time than standard treatment. You may have to:
- Make more trips to the study
- Have more treatments.
- Receive your treatment in a
- Take more medicine more often or at very specific times.
- Keep a written diary of your experience.
How is your safety protected?
Every clinical trial
in the United States must be approved and monitored by an
institutional review board (IRB) to make sure that the
risks are as low as possible and are worth any potential benefits.
The ethical and legal rules for medical practice also apply to
clinical trials. Most clinical research is regulated by the U.S. government,
with specific rules to protect the participants. Clinical trials follow a
carefully controlled study plan (protocol) that explains what everyone will do
in the study. During the clinical trial, researchers report the results of the
trial at scientific meetings, to medical journals, and to government agencies.
Your name will remain secret and will not be mentioned in these reports.