Clinical trials are designed using experimental standardized plans, which sometimes can be very complex. These standardized plans, called “protocols,” are developed as part of every clinical trial and provide a framework for the objective collection and analysis of data, and the protection of study volunteers. The development of clinical trial protocols is initially based on laboratory and animal research, and sometimes on other clinical trials involving human beings. In the case of an experimental treatment for a disease, the protocol would identify exactly what procedures would be followed to determine effectiveness against a specific disease and any side effects that occur. Oncologists and oncology nurses (doctors and nurses specializing in cancer, respectively) follow the protocols in order to accurately collect data for research.
Before a clinical trial can begin, a scientific and ethical review board, called an Institutional Review Board (IRB), evaluates the proposed clinical trial protocol to determine whether it is safe, scientifically sound, and appropriately designed, and also to ensure that patients are appropriately protected. This board is made up of health care professionals, administrators, and lay persons. All clinical trials using drugs, devices, or procedures not yet licensed by the FDA must receive the approval of the appropriate IRB before any patients are allowed to volunteer for participation.