What is a Clinical Trial?

 A clinical trial is a carefully designed study that is done with people like you who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Pharmaceutical and biotechnologies have developed these treatments, and these companies have then selected physicians, also called investigators, who are qualified to conduct clinical trials. It is through these trials that investigational drugs may show their benefits.
 The clinical testing of an investigational drug is a step-by-step process that ensures you receive careful medical attention. All clinical trials are reviewed by the U.S. government's Food and Drug Administration (FDA) and by Institutional Review Boards (IRBs).
 IRBs are independent committees whose job is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks. IRBs also are responsible for ensuring you sign a consent form before agreeing to participate in a trial.
 Clinical trials usually are conducted in three phases (I, II, III). A small number of people participate in Phase I trials. Each later phase involves a larger number of people.
 In a clinical trial, a volunteer is usually assigned to a specific study group. Sometimes volunteers in one study group will receive an investigational treatment or study drug. Sometimes volunteers will receive a placebo or a treatment already available.
 A placebo is an inactive product used to compare the results of the study drug. You, your physician and the research staff may not know who is receiving a placebo and who is not. In this way, volunteers in a clinical trial can be observed by the physician and research staff more fairly. Whether you receive the placebo or the investigational drug, the level of medical attention and care that you receive is the same.