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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 in a clinical trial depends on the type of clinical trial being conducted.
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.
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.
If you agree to take part in a study, there may or may not be direct medical benefit to you. Potential benefits include:
The potential risks include:
Even if a new approach has benefits, it may not work for you.
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