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.
Who pays for clinical trials?
Sometimes the group sponsoring your trial will be responsible for the
cost of the medicine as well as the costs of medical tests that are required
while you are in the trial. (Clinical trials usually require you to have more
medical tests than you would have if you were not in the trial.) But in other
trials, the cost of the medicine and only some of the medical tests will be
covered. Some studies will reimburse you for the cost of traveling to and from
your medical visits.
How can you find out about clinical trials?
National Institutes of Health, through its National Library of Medicine, has
developed ClinicalTrials.gov to provide information about clinical
research studies to patients, family members, and members of the public. You
can contact this service on the Internet at www.ClinicalTrials.gov. Or you can
get information over the phone by calling 1-888-346-3656 or (301) 594-5983.
There may or may not be a clinical trial available in your area that relates to
your particular disease or stage of disease.