Medical research studies are scientific investigations that shape the future of medicine by helping us find:
- new medicines
- new formulations of previously approved medicines
- new uses for previously approved medicines
Before introducing any new medicines to the public, pharmaceutical companies must test their investigational drugs very carefully through medical research studies (also called “clinical trials”.) Global regulatory agencies, such as the United States Food and Drug Administration and Health Canada, thoroughly review the data collected in these studies before approving new medications for the public. Once a drug is approved, many pharmaceutical companies continue to conduct research on the approved drug to collect ongoing safety and effectiveness data.
Study doctors are required to follow strict rules to protect the safety of the people who volunteer to participate in clinical trials. All researchers must follow a detailed plan, called a protocol, which explains all study procedures. The protocol has been reviewed by an independent board (or group of people) that oversees the safety of all study participants. Additionally, before enrolling individuals into a study, researchers must fully explain the study to the individual and answer any questions he or she may have. Participation in a clinical trial is voluntary, and individuals may withdraw from a study at any time for any reason. Participants may or may not benefit from the investigational drug.