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The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps
Session Chair(s)
Susan S. Ellenberg, PhD
Professor, Biostatistics; Associate Dean for Clinical Research
University of Pennsylvania, United States
Findings from the Clinical Trials Transformation Initiative (CTTI) Data Monitoring Committee (DMC) Project survey and focus groups will be presented. Specific topic areas include: use, conduct, communication practices and training issues related to DMCs.
Learning Objective : Describe key themes that emerged from the project survey and focus groups; Discuss how findings from these activities were analyzed and will be applied to project next steps.
Speaker(s)
Introduction to the Clinical Trials Transformation Initiative Data Monitoring Committees Project
Karim Calis, PharmD, MPH
FDA, United States
Senior Clinical Analyst, Office of Medical Policy, CDER
Data Monitoring Committee Communication Practices Among Key Stakeholders
Raymond P. Bain, PhD
Merck Research Laboratories, United States
Vice President, Biostatistics and Research Decision Sciences
Data Monitoring Committee Qualification, Composition and Training
Jane Perlmutter
Patient Advocate, United States
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