Next time you're in a drugstore, consider this: Every medication and medical device for sale has undergone rigorous testing before landing on the shelves.
These tests are called clinical trials. Without them, advances in the treatment of disease would be impossible. At the heart of these trials are the ordinary people who step forward and lend their bodies to science. "There is no way for therapy to advance without some people participating," says Paul Strumph, M.D., vice president and chief medical officer of the Juvenile Diabetes Research Foundation International.
The question is: Should you be one of them?
How Trials Work
Clinical trials determine whether a drug, therapy, or device is safe and effective before the U.S. Food and Drug Administration (FDA) will approve its use by consumers. "In diseases where there's not a perfect treatment, and there's a desire to advance therapy, there will always be new devices and drugs that need to be tested," Strumph says.
Clinical trials often emerge from research labs, where tests in animals have shown promise. Researchers then create a trial protocol, which must be approved by an institutional review board -- an independent committee of physicians, statisticians, and laypeople that ensures the risks are small and worth the potential benefits.
Clinical Trial Terms
Control group: The participants who do not receive the new treatment, drug, or device being studied. They receive standard treatments and/or placebos.
Double-blind study: Neither the participants nor the researchers know the makeup of the test and control groups during a study.
Protocol: Description of the objective, design, methodology, statistical considerations, and organization of a clinical trial.
Randomized study: Test subjects are assigned randomly (by chance) to different treatment groups.