DMS's Role When Post-Marketing Commitment Study Is Unlikely to Be Completed

• Activity Number: 46
• Type: Invited
• Date/Time: Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Janet Wittes*+
• Companies: Statistics Collaborative
• Keywords: Data Monitoring Committees ; post-marketing committment ; drug development

Abstract

It is a not a secret that the quality of many randomized post-marketing commitment studies is less than ideal. Recruitment may be agonizingly slow; the investigators involved may be unenthusiastic; the Sponsor may assign a relatively weak team to the trial. In such cases, the members of the DMC - if there is one - may find themselves at odds with the Sponsor and unwilling to continue to participate in their role. Yet the participants in the trial have given their consent to randomization and to follow the protocol. If their contribution is to be meaningful, the study must be completed in a way that leads to success, where "success" means producing interpretable results. This talk addresses strategies DMCs have taken to ensure that the post-marketing trial they are monitoring have a high likelihood of being successful.