What Are the Risks of Clinical Trials?


Enrolling in a clinical trial that researches new drug treatments (or that uses old ones in a different way) is a great option for some people with breast cancer. It may give you access to cutting-edge treatments that would otherwise be out of reach. It's wise to fully discuss the details with your doctor, however, and to understand the way trials work and what your participation would entail.

If you choose to enroll in a clinical trial, you can play a more active role in your own health care, gain access to new research treatments or drug treatments before theyre widely available, and help others by contributing to medical research, according to clinicaltrials.gov.

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

Clinical trial risks

  • The experimental treatment may not work as well as standard treatments you may have been prescribed otherwise.
  • You may experience unpleasant side effects from the treatment. These side effects could even be serious or life-threatening.
  • The treatment may not work.
  • The new treatment might require more time and commitment than your standard treatment. You may be asked to:
    • Commute back and forth to the study site.
    • Receive more treatments than you normally would.
    • Receive treatment in a hospital or a site other than your own hospital.
    • Take more medicine than usual, more frequently or at rigidly prescribed times.
    • Keep a written diary of your experience in the trial.

How am I protected from these risks?
All clinical trials in the United States must be approved and monitored by an institutional review board to verify risks are as low as possible and are worth any potential risks.

The ethical and legal codes that apply to medical practice also apply to clinical trials. There are special rules to protect participants, and the trials follow a controlled study plan. Your name will remain confidential and will not appear in any reports.