Reporting Only ‘Unanticipated’ AEs of Trial Drugs Would Reduce IRB Workload, But Would Patient Safety Suffer?

By Cara Angelotta, David Dorr, MD, MS, and Charles L. Bennett, MD, PhD, MPP | November 1, 2006

While IRBs are hopeful that the changing policies will make it easier to identify unanticipated, serious side effects, more empirical evidence is needed to ensure that this new guidance does not harm patient safety.

Ms. Angelotta is a project coordinator in Dr. Bennett’s office. Dr. Dorr is assistant professor of medical informatics and clinical epidemiology, Oregon Health & Science University. Dr. Bennett is professor of medicine, Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine; co-leader, Cancer Control Program, Robert H. Lurie Comprehensive Cancer Center of Northwestern University; and associate director, Midwest Center for Health Services & Policy Research, Jesse Brown VA Medical Center-Lakeside CBOC.

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1. Lazarou J, Pomeranz BH, Corey PN: Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 279:1200-1205, 1998.
2. Lasser KE, Allen PD, Woolhandler SJ, et al: Timing of new black box warnings and withdrawals for prescription medications. JAMA 287:2215-2220, 2002.
3. Emanuel EJ, Wood A, Fleischman A, et al: Oversight of human participant’s research: Identifying problems to evaluate reform proposals. Ann Intern Med 141:282-291, 2004.

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Reporting Only ‘Unanticipated’ AEs of Trial Drugs Would Reduce IRB Workload, But Would Patient Safety Suffer?

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