What is a Clinical Trial

Understanding Clinical Research Studies or Drug Trials

What is a drug trial?

A drug trial is a carefully controlled experiment in which people take a drug that has either 1) never been approved by the U.S. Food and Drug Administration (FDA) or 2) been approved by the FDA for one medical condition but is being studied for the treatment of a second. A drug trial determines if a drug works and if it is safe. Drug trials are also called clinical research studies.

The effects of the drugs being tested in trials are not known. It’s important to be aware of the risks, as well as any possible benefits of participating in a clinical trial. Every drug trial is different, so it’s important to find out exactly what might be expected to happen before you join.

Why are drug trials done? Why can’t I just take the drug I want?

Drug trials are done to find out which ones work, and which ones don’t. Every drug sold in the U.S. must first be approved by the Food and Drug Administration (FDA). The FDA carefully reviews the information from drug trials to determine that the drug is safe and that it works. If the drug is safe and effective, the FDA gives permission for the drug company to sell it. It is usually against the law to sell a drug if it has not been approved by the FDA. An insurance company, Medicaid or Medicare usually will not pay for a drug or treatment that has not been reviewed and approved by the FDA.

What drugs are being tested?

People are taking many different things to try to fight diseases. Most trials test drugs, although some are now testing other possible treatments, such as vitamins. In some trials, more than one type of treatment, or a combination of drugs is being tested. In others, a new medical device may be tested.