Clinical Trial Protocol

The clinical trial process depends on the kind of trial being conducted. Every protocol, or study plan, is carefully designed to safeguard the health of the participants, as well as answer specific research questions. The protocol defines: what types of people may participate in the trial; the trial’s schedule of tests, procedures, medications, and dosages; and the length of the study.

During a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Trials may be conducted in hospitals, universities, doctors' offices, or community clinics.

Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) -- a committee of physicians, statisticians, researchers, community advocates -- to make sure that the potential risks to trial participants are minimized and that the probable benefits of the trial outweigh those risks.  All institutions that conduct or support biomedical research financed by federal funds and involving people must be reviewed by an IRB.

Physicians and medical personnel involved in clinical trials are bound by ethical and legal codes that govern standard medical practices.  In addition, most clinical research is regulated by the federal government to further protect the health and safety of the participants.  Every trial must follow a carefully controlled protocol, or study plan that details what researchers will do during the trial. As a clinical trial progresses, researchers report the results of the trial to colleagues, medical publications, and various government agencies.