What is a clinical trial protocol?

You might have heard the term clinical trial when you were looking up information about a new medication or other treatment. A clinical trial is a health-related research study using human beings as the study subjects. These studies are based on a study plan called a protocol. This plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. The protocol describes who may participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study.

While in 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. In the United States, all clinical trials are approved by the Food and Drug Administration and then are reviewed and approved by each hospital's Internal Review Board to ensure patient safety.