The Role of the Data-Monitoring Committee: The Past and the Present in Preparation for the Future

• Activity Number: 228
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): John Loewy*+
• Companies: Dataforethought
• Keywords: DMC ; regulatory ; group sequential ; interim analyses ; adaptive designs

Abstract

Since the 1960's randomized controlled clinical trials have used independent data monitoring committees (DMC) to evaluate the ongoing accumulation of clinical trial data for which the treatments being received are blinded to the patient, the investigator, and the sponsor. Building on what was originally an NIH backed activity, pharmaceutical company sponsored group sequential trials have provided the foundation for facilitating the review of unblinded interim analyses since the early 1990's in a regulatory environment. This presentation will combine the past with the present, to underscore the roles and responsibilities, conventional and evolving, in which a DMC participates to ensure that clinical trial subjects are not being harmed by the experimental treatments received in concert with other treatment comparison objectives. As clinical trial objectives become increasingly more complex and specialized, we will introduce a foundation of practices already in place to prepare DMC's for the challenges being discussed in the present and those envisioned for the future.