What Is a Clinical Trial and Who Participates?

Dr. Jasjit S. Ahluwalia

You may have seen advertisements seeking "men and women age 18-55 who have chronic bronchitis" or "healthy smokers who want to quit smoking" to participate in clinical trials to test new treatments. But just what is a clinical trial and what does participation involve?

A clinical trial is a research study designed to assess the effects of a new treatment. The treatment could be a new medication, a device, such as a pacemaker or insulin pump, or an intervention, such as an exercise program or counseling session. The purpose of a clinical trial is to discover whether a new treatment is better, worse or equal in its ability to treat a condition compared with an existing treatment.

Just because you enter a clinical trial does not necessarily mean you will receive the new treatment being tested. Clinical trials are usually randomized, meaning you may be placed in one of two or more groups: the treatment group which receives the new treatment; the control group, which may receive a placebo (often a sugar pill); and possibly another group that would receive existing therapy. The purpose is to measure the effectiveness of the new treatment. Often, neither you nor the researchers will know what group you are in. This is to ensure that the results of the trial are not influenced by you or the researchers knowing what treatment you received.

Your participation in clinical trials can be beneficial. Clinical trials sometimes offer cutting-edge treatment options not readily available to the public. Some people enter trials to satisfy their curiosity about a medical condition they might have, others enjoy contributing to scientific knowledge, and some have exhausted existing approved therapies and want to try experimental treatments before giving up.

Many are concerned about safety in clinical trials. Clinical trials can involve varying degrees of risk. Some trials may present a very low risk to the participant, while others, such as studies involving very ill patients, may present a higher risk. Very ill patients may believe it's worth the risk to try a new treatment.

At the University of Minnesota and other universities, all clinical trials are reviewed by a board of scientists, ethicists, and community members to determine risks to potential participants. Often, researchers must revise and resubmit their proposals several times before receiving approval to begin. In university-sponsored research, no researcher is permitted to begin a clinical trial without the approval of this board, and all researchers are required to fully explain what the trial entails to participants before they enter the trial. Also, you should ask questions about the risks and benefits of the research before participating.

Although clinical trials are often conducted by health-care providers, it is essential that you notify your own physician or primary care provider, since participation in a clinical trial may affect your current course of treatment. You should also feel free to ask questions of both the researchers and your health-care provider before participating in a clinical trial to find out how the trial could affect your current care.

If you are interested in participating in a clinical trial, a Web site hosted by the University of Minnesota Office of Clinical Research lists trials at the University and some other locations in Minnesota. To view the lists go to: http://www.ahc.umn.edu/ocr/partner/trials/home.html

Jasjit S. Ahluwalia, M.D., M.P.H., M.S., is the executive director of the Office of Clinical Research at the University of Minnesota.

This column is an educational service of the University of Minnesota. Advice presented should not take the place of an examination by a health-care professional. For more health-related information, go to http://www.healthtalk.umn.edu.