Data Monitoring Committees Operations

• Activity Number: 617
• Type: Contributed
• Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Tingting Li* and Yao Yao and David Kerr and Kent Koprowicz
• Companies: Axio Research and Axio Research and Axio Research and Axio Research
• Keywords: DMC ; Operations ; Data Monitoring Committees ; Clinical Trial

Abstract

Data Monitoring Committees (DMC) monitor safety and study conduct for clinical trials on an ongoing basis. Usually, DMC meetings are scheduled to review unblinded safety data (from clinical database and Pharmacovigilance database) approximately every 4-6 months. Following each interim data review, the DMC will recommend continuation of the study with or without modification or discontinue the study because of safety concerns. Interestingly, there is no universal rule for DMC operation. For example, what kind of data will be provided to the DMC (key safety information or all information including efficacy); how long should data cleaning take (fresh vs clean); format of DMC report (200 pages vs 2000 pages); whom at sponsor side should receive the DMC recommendation; shall the sponsor and DMC have a second open session after the closed session and etc. This presentation will compare different approaches. Advantages and disadvantages of these approaches will be further elaborated.