What are Clinical Studies?

Clinical studies are used to prove that a drug is effective and safe. An experimental medication must go through a series of clinical studies (which may also be called clinical research trials or clinical trials) to prove that it is a safe and effective treatment for a particular medical condition. Clinical studies may be small, evaluating a drug’s effects in only a few participants, or large with thousands of participants. Clinical Studies are conducted by qualified doctors who are responsible for the care and well being of the participants.

All clinical studies must follow a strict set of rules, or “protocol.” Before any clinical study begins, the protocol must be reviewed and approved by proper regulatory authorities such as the United States Food and Drug Administration (FDA) or Health Canada, and an Institutional Review Board (IRB), which may also be known as an ethics committee or ethics review board.

An IRB is an independent committee of medical and non-medical members that assesses a clinical study’s potential risks and benefits to ensure that the participants’ rights and welfare are protected, and that participants are fully informed about all aspects of the study. Ultimately, it is only after the data from numerous clinical studies have been evaluated that an investigational medication may receive approval from a regulatory agency such as the FDA or Health Canada and become available to the public.

Visit clinicaltrials.gov to learn more about clinical research trials by clicking here.