Medicines are as diverse as the conditions they treat. Yet each medicine has something in common — its safety and effectiveness must be proven in order to receive approval from a regulatory agency such as the U.S. Food and Drug Administration. To do so, each medicine goes through a series of clinical trials, also called clinical studies, which are scientific studies aimed at understanding how a medicine works in a person.
Clinical trials involve years of rigorous testing of a potential medicine in various populations to evaluate its safety and effectiveness in people. A medicine begins as a molecule in the laboratory, where we study what medical conditions it may address. Promising treatments then advance to clinical studies. Each phase of a clinical study has a different goal, including determining dosage, evaluating side effects, and measuring effectiveness. This rigorous process takes many years, and the vast majority of potential medicines do not succeed.
People who take part in clinical trials may receive access to a potentially beneficial treatment and high-quality care. They also play an integral role in the development of a new medicine. Their participation provides important information about the safety and effectiveness of a treatment and generates a wealth of information that can lead to the identification of other innovative medicines. By raising awareness about the availability of clinical studies, educating people about how they work, and encouraging eligible people to participate, we can accelerate the development of potentially lifesaving treatments.