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Clinical Trials

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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.

If the 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.

Your treatment 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 standard treatments.
  • You may have unpleasant, serious, or even life-threatening side effects from the treatment.
  • The 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 site.
    • Have more treatments.
    • Receive your treatment in a hospital.
    • 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?

The U.S. 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.

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WebMD Medical Reference from Healthwise

Last Updated: October 31, 2011
This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
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