Karim Anton Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Jane Perlmutter, PhD, Patient Advocate
Dave DeMets, PhD, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin - Madison
This webinar covers CTTI's recommendations on best practices for the use of Data Monitoring Committees (DMCs), intended to enhance the functioning of a DMC, beginning with training of members. Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others. CTTI's recommendations can help to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.