Post Marketing Commitments: Study Designs and Their Implications for DMCs

• Activity Number: 46
• Type: Invited
• Date/Time: Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Susan S. Ellenberg*+
• Companies: University of Pennsylvania
• Keywords: data monitoring committee ; post-marketing commitment ; clinical trial ; product safety

Abstract

Studies performed to fulfill post-marketing commitments range from single-arm studies performed simply to collect more information on drug effects, to randomized double-blind studies to evaluate long-term clinical effects of drugs receiving accelerated approval, to single-arm or randomized studies intended to further assess a potential safety signal identified in pre-market studies. Each type of study has different implications for data monitoring. Not all post-marketing studies will require a formal, independent DMC. Studies performed specifically to assess a potential safety signal, or where the outcome being evaluated is mortality or another serious event, will most likely require such oversight.