A clinical trial is the scientific study that tests the safety and effectiveness of a potentially new medical treatment or medical device on human volunteers. All investigational products will have previously undergone rigorous testing in the laboratory before testing can begin in humans.
The investigational medication may be a new or already FDA approved medication. The clinical trial may compare a new drug or treatment with an already approved FDA medication, with a placebo or with both a placebo and an already approved FDA medication depending on the goals of the clinical trial.
The FDA uses information from clinical trials to approve or deny applications to market these treatments to the public.
Other terms often used to describe clinical trials are clinical research trials, trials, clinical studies, drug studies, studies or drug research.
The development of an innovative new treatment is often a lengthy and costly process. Clinical trials are carried out under the strict supervision of fully qualified doctors, nurses and other health care professionals who follow strict regulatory and protocol guidelines.
All clinical trials must first be approved by an Independent Review Board (IRB). IRBs are comprised of both people in the community (clergy, parents, business owners, students, etc.) and professionals (i.e., physicians, nurses, attorneys, etc.) with their main concern of safeguarding the interests of the volunteer participants.