Clinical research studies are scientific investigations that shape the future of medicine by helping us find:
- new medicines
- better formulations of old medicines
- new uses for old medicines
Before introducing new medicine to the public, pharmaceutical companies must test their investigational drugs very carefully through medical research studies (also called “clinical trials”). The United States Food and Drug Administration thoroughly reviews the data collected in these studies before authorizing 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 research studies. All researchers must follow a detailed plan, called a protocol, which explains all study procedures and 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 research study is voluntary, and individuals may withdraw from the study at any time for any reason. Participants may or may not benefit from the investigational drug.