The purpose of Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs) is to protect the safety of clinical trial participants, maintain trial integrity and scientific validity during the drug or product development process. Clinical protocols designed to evaluate patient health outcomes based on safety and efficacy may suggest the need for these committees to implement data risk assessment and analysis.
This interactive webinar session will address the current status of US and EU Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs) with a perspective on their activities and best practices to address efficacy and safety issues for clinical trials. The practical examples of working with DSMBs/DMCs and outcomes of discussed issues will be shared and explored.
Organized by:
Drug Information Association
Invited Speakers:
SUSAN ELLENBERG,, PHD Professor of Biostatistics, Associate Dean for Clinical Research University of Pennsylvania School of Medicine.
MONIIKA PIIETREK,, MD,, PHD,, MSC Executive Vice President, Global Scientific and Medical Affairs PRA International.