A clinical trial is a research study in which the participants receive investigational medicine(s) under the supervision of a study doctor and other research health care professionals to study the effects of the investigational medicine. Clinical trials follow a strict set of rules to ensure that study participants are protected and that the investigational medicine(s) is tolerated and correctly analyzed for safety and effectiveness. Regulatory authorities, like the Food and Drug Administration (FDA) in the United States, review clinical trial information and make decisions about whether to approve investigational medicines.
There are 3 phases of clinical trials (clinical studies) before an investigational medicine is considered for approval by a regulatory authority. Phase 1 usually involves a small number of participants to decide on a safe dose followed by Phase 2 and 3 studies which involve larger numbers of participants to test the safety and effectiveness) of the investigational medicine.
Institutional Review Boards (IRBs) review and approve clinical study protocols. The clinical study protocol is a document that describes how a clinical study will be conducted, including the objective(s) and study design. IRBs ensure the safety of study subjects and ensure the data collected is of high quality.
Click here to go to a helpful resource, ClinicalTrials.gov, where you can learn more about clinical trials and search for other clinical trials.