Understanding Clinical Trials and Research Studies

A clinical trial (also called clinical research) is a research study using human volunteers to answer specific questions about medications and procedures. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials to gather information about the effects of the treatment or procedure on humans.  Trials may be sponsored or funded by physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies in addition to federal agencies such as the National Institutes of Health (NIH), the U.S. Department of Defense (DOD), and the U.S. Department of Veterans Affairs (VA).

Participants in clinical trials play a more active role in their own health care, gaining access to new research treatments before they are widely available, and helping others by contributing to medical research.  However, even the best-designed clinical trials have risks, including unpleasant, serious or even life-threatening side effects to treatment; ineffective treatment; or longer and more complicated treatment.