What Are the Risks of Clinical Trials?

You should be fully informed about the possible risks and benefits of the trial before you consent to participate.

What are the risks of clinical trials?

• The new treatment may not work as well as standard treatments.
• You may experience 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 frequently or at rigidly prescribed times.
  • Keep a written diary of your experience.

How is my safety protected?
Every clinical trial in the United States must be approved and monitored by an institutional review board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

The ethical and legal codes that apply to 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.