Clinical trials are required to prove the safety and efficacy of new medications in order to obtain FDA approval for marketing. These studies are typically divided into four different stages: Preclinical testing is generally done first in animals. The studies are then conducted in a small sample of healthy volunteer study participants. Next, studies are performed in larger groups of participants who have the actual disease or condition. Once the treatment is approved for marketing by the FDA, additional information may be collected from many patients in a post-marketing surveillance program to establish a broader usage.
Clinical trials are conducted under very careful supervision by the pharmaceutical companies and the FDA during and throughout the studies, and according to strict guidelines outlined prior to starting any study. Volunteer safety and health status information is carefully monitored via physician and research coordinators as well as by pharmaceutical company representatives throughout each study participation and follow-up period. Approval by an independent Institutional Review Board (IRB) is required prior to and throughout the course of every research study. The IRB is dedicated to the protection of study volunteers and includes members of the medical and legal professions as well as the general public (such as religious leaders, social workers, and well informed citizens).