Clinical trials are governed by the Food and Drug Administration regulations and may involve drugs, devices, food substances, or a medicinal preparation created by a biological process.
“A clinical investigation defined as any experiment that involves a test article (i.e., drug, device, food substance, or biologic) and one or more human participants that either is subject to requirements for prior submission to the FDA (IND, IDE requirements), or not subject to these requirements, but the results will be submitted later to the FDA or held for inspection by the FDA as part of an application for research or marketing permit.” (21 CFR 50.3(c), 21 CFR 56.102(c))
Clinical trials can occur in a variety of settings such as a medical office, a community clinic, or a hosptial. Clinical trials must all be approved by the IRB before they are allowed to begin.
There are two types of clinical trials:
- Therapeutic: These studies will provide a direct medical benefit to the research participants.
- Non-therapeutic: These studies provide no direct medical benefit to the research participants but help the researchers learn more so that future generations may benefit.