Clinical drug and biologics trials should aim to have participants represent the likely users of the approved medication. The FDA has issued guidance for sponsors that recommends approaches to increase enrollment of underrepresented populations in clinical trials.
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
CITI Program’s Research Ethics Training
Human Subjects Research (HSR)
HSR provides foundational training in human subjects research and includes the historical development of human subject protections, ethical issues, and current regulatory and guidance information.
Good Clinical Practice (GCP)
GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.