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Clinical Trials

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Topic Overview

What is a clinical trial?

Clinical trials are research studies in which people help doctors find ways to improve health care. Each study tries to find better ways to prevent, diagnose, or treat health problems.

The purpose of a clinical trial is to find out whether a medicine or treatment is safe and effective for treating a certain condition or disease. Clinical trials compare the effectiveness of this medicine or treatment against standard, accepted treatment or against a placebo if there is no standard treatment.

Taking part in a clinical trial is voluntary. No one can make you participate. If you choose not to take part, you will be offered the standard treatment for your health problem. You can talk to your doctor if you have questions about clinical trials.

Why are they important?

Clinical trials are important because they compare new treatments with accepted treatments. They allow researchers to find out if a new treatment works as well as or better than accepted treatments. The new treatment might have fewer or less serious side effects. The new treatment also might not work as well or might cause more side effects than standard treatments.

Clinical trials help drug companies make medicines that are safer and more effective with fewer side effects. Clinical trials also help these companies decide whether it is worthwhile to seek approval from the U.S. Food and Drug Administration (FDA) for a certain medicine. If a medicine doesn't work as well as standard treatment, then the FDA isn't likely to approve it.

Clinical trials are also important in finding treatments if no standard treatment exists.

Taking part in a clinical trial may not benefit you directly. But in the future it may help other people who have the same disease.

How do clinical trials work?

Your doctor will help you find out if you are eligible to take part in a clinical trial. The company sponsoring the trial will have a very strict set of standards, or criteria, that all participants must meet.

If you meet the criteria, you may be "randomized" to get either the new medicine, a medicine that is considered standard therapy, or a placebo. That means that a computer is used to randomly assign you to one of the treatments. In many studies, neither you nor your doctor knows which treatment you are getting. But not all clinical trials randomize people. And if you have a serious disease, such as cancer, you will not be given only a placebo, unless no effective treatment is known.

After you are accepted by the clinical trial and you give your consent to take part:

  • You will be given a structured program to follow.
  • You will have a schedule of tests, doctor appointments, and treatments.
  • You may be asked to keep a diary of your experience during this time.

Doctors, nurses, social workers, and other health professionals may be part of your treatment team.

Be sure to carefully follow instructions. If you don't know what you are supposed to do next, call your doctor. Or call the person responsible for your trial.

A medicine or treatment must go through three phases before it is approved for use by the U.S. Food and Drug Administration (FDA).

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WebMD Medical Reference from Healthwise

Last Updated: October 31, 2011
This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
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