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A clinical trial is a research study designed to evaluate a new treatment approach. Clinical trials are the only way new treatments can emerge that improve the lives of people with cancer.

A clinical trial often starts with a scientific idea, based on the results of laboratory research. The researchers who bring forth these ideas usually work in cancer centers, universities, hospitals, community clinics or pharmaceutical company labs.

There are many types of cancer clinical trials, including treatment, screening, prevention, symptom management and quality of life. This booklet focuses on cancer treatment trials that evaluate medications (drugs). However, it is important to note that other treatment methods—including surgery and radiation—are also evaluated in clinical trials.

Many clinical trials test an already-approved drug, for use in a different way or to treat a different disease. Other trials evaluate a drug (or a combination of drugs) not previously given to humans, to make sure the approach is safe and will provide benefit to patients.

Many times, researchers and doctors study a new drug in the laboratory before a human clinical trial is designed and proposed. Among other things, they want to know how the drug is absorbed into the body, how long it remains in the body, the maximum tolerated dose and whether it should be given by mouth or intravenously (through a needle into a vein).

If supported by the results of the laboratory study, researchers and doctors create a Clinical Protocol, a detailed blueprint of every aspect of the trial. The clinical trial sponsor then submits an Investigational New Drug (IND) application and the Clinical Protocol to the U.S. Food and Drug Administration (FDA). The FDA has 30 days to review the IND and Clinical Protocol to both provide input and to assure that the trial will safely and ethically evaluate the drug and that the trial participants will not be subjected to unreasonable risk. (A clinical trial sponsor is a person, group, company, institution, organization or government agency that oversees or pays for a clinical trial, and collects and analyzes the data.)

When discussing your treatment options with your oncologist, ask if a clinical trial might be right for you. Clinical trials are routinely integrated into the treatment plan for people with cancer.

Here a few things to consider:

  • Most clinical trials are designed to test a new treatment approach to find out whether the approach is safe and has any added benefit.

  • Often, people who take part in clinical trials gain access to—and potential benefit from—new treatments that are not otherwise available.

  • All clinical trials have eligibility requirements, and you may or may not qualify to participate in any specific trial.

  • Before you participate in a clinical trial, you will be fully informed of the risks and benefits of the trial, including any possible side effects.

  • You have the right to stop taking part in a clinical trial at any time for any reason.

The Resource section of this booklet provides websites that allow you and your doctor to search for a clinical trial that might be right for your individual circumstances, including your type of cancer and your geographic location.

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Thumbnail of the PDF version of Clinical Trials: Improving the Care of People Living With Cancer

Download a PDF(533 KB) of this publication.

This booklet is supported by Bristol Myers Squibb, an educational grant from Daiichi Sankyo, Inc. and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC.

Last updated Saturday, April 30, 2022

The information presented in this publication is provided for your general information only. It is not intended as medical advice and should not be relied upon as a substitute for consultations with qualified health professionals who are aware of your specific situation. We encourage you to take information and questions back to your individual health care provider as a way of creating a dialogue and partnership about your cancer and your treatment.

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