- A prospective study involving human subjects designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions; these may include drugs, treatments, surgical procedures, devices, behavioral or nutritional strategies. Clinical trials are typically conducted by investigators who have entered into an agreement with a sponsor to conduct the study. For clinical drug and device trials, investigators agree to conditions regarding the conduct of the study outlined by FDA.
- A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (hyperlink each Phase)
Not all human subject research projects are ‘clinical trials’.
