title: Ensuring participant safety and trial integrity with clinical trials oversight.
abstract: Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local Institutional Review Board, and independent monitoring committees all contribute with complementary but overlapping responsibilities. Consistency among these groups is essential for the smooth conduct of a clinical trial but may be challenging in resource-limited settings (RLS). Capacity building and training for RLS may improve clinical trials oversight and ultimately medical management. In this article, we review the components necessary for optimal clinical trial oversight and the issues that arise in the RLS, with some suggested strategies for improvement.
authors: *HIV Research Branch and the Office of Clinical Site Oversight at the Division of AIDS, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD; †PRA International, Raleigh, NC; and ‡Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, WA.
authors: Catherine
authors: C
authors: Godfrey
authors: Manizhe
authors: M
authors: Payton
authors: Sybil
authors: S
authors: Tasker
authors: Scott
authors: S
authors: Proestel
authors: Jeffrey T
authors: JT
authors: Schouten
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000458:organization & administration / Q000592:standards; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000592:standards*; D028744:Ethics Committees, Research; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control; D006295:Health Resources; D006801:Humans; D061214:Patient Safety; D060735:Pharmacovigilance; D035842:Research Subjects; D018570:Risk Assessment