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Frequently Asked Questions about Cancer Clinical Trials

What is a Clinical Trial?

A clinical trial is a research study. People who agree to participate in clinical trials (also referred to as clinical studies) agree to try a new treatment for their disease. Clinical studies are conducted under careful medical supervision. Clinical trials include only those people who choose to take part.

What happens during a Clinical Trial?

What happens in a clinical trial depends on the type of clinical trial being conducted.

  • Treatment trials test new treatments or new a combination of treatments.
  • Prevention trials try to prevent disease in people who have never had the disease.
  • Observational Studies are data collection studies that try to answer questions about people who have a specific disease.

What is informed consent?

Informed consent is the process of learning about a clinical trial before deciding to participate or not. The doctors and nurses involved in the study explain the details of the study and also provide an informed consent document. This process continues throughout the study, providing new information to participants as it becomes available.

Can I leave a Clinical Trial if I change my mind?

A participant can withdraw consent (leave a clinical trial) at any time. It will not affect your relationship with your doctor and you will continue to receive the best care that your doctor can offer, but if the treatment you are receiving is not yet approved for your disease it may no longer be available for you to receive outside of a clinical trial. Therefore it is important before joining a clinical study to think about it, ask questions and discuss it with your family.

What are the benefits in taking part in a Clinical Trial?

If you agree to take part in a study, there may or may not be direct medical benefit to you. Potential benefits include:

  • Healthcare provided by leading physicians in the field of cancer research.
  • Access to new drugs and interventions before they are widely available.
  • Close monitoring of your healthcare and any side effects.
  • A more active role in your own healthcare.
  • If the approach being studied is found to be helpful, you may be among the first to benefit.
  • An opportunity to make a valuable contribution to cancer research.

The potential risks include:

  • New drugs and procedures may have side effects or risks unknown to the doctors.
  • New drugs and procedures may be ineffective, or less effective, than current approaches.

Even if a new approach has benefits, it may not work for you.

What is a placebo?

In the strictest sense, the technical term placebo denotes the inert, dummy simulator of an "active" drug. The placebo serves as a control in the clinical trial setting, it contains no active ingredients. Placebo's are rarely used in cancer treatment trials. If the trial has a placebo "arm," it will be clearly identified in the consent form.

Last Updated: 6/24/2009