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Session 12: Mastering FDA’s New Draft Guidance: Optimizing Data Monitoring Committees in Clinical Trials
Session Chair(s)
Susan Kindig, JD, MD
Prior Executive Director, Medical and Drug Safety
United States
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
This session will provide an introduction and overview of the newly-released FDA Draft Guidance on Use of Data Monitoring Committees (DMC) in clinical trials. Valuable practical information will be provided to enable safety professionals to better evaluate DMC charters and support the implementation of DMCs. In addition, the potential use of DMCs in IND reporting decisions for anticipated events in the study population will be discussed.
Learning Objective : - Interpret the new FDA Draft Guidance published in Feb 2024, “Use of Data Monitoring Committees in Clinical Trials” (“DMC Draft Guidance”)
- Describe common misconceptions of DMCs and best practices for training of DMC members
- Illustrate how a DMC can effectively assist safety organizations in evaluation of potential safety signals in ongoing clinical trials
Speaker(s)
Speaker
Keith Verrett, JD
FDA, United States
Regulatory Counsel, Office of Medical Policy, CDER
Speaker
Frank W. Rockhold, PhD, MSc
Duke Clinical Research Institute, Duke University Medical Center, United States
Professor of Biostatistics
Speaker
Melvin Slaighter Munsaka, PhD, MEd, MS
AbbVie, United States
Senior Director, Head Safety Statistics