Creating a Better, Shorter DMC Report: A Stack of Needles, Not a Needle in a Haystack

• Activity Number: 522
• Type: Contributed
• Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): David Kerr*+ and William Coar and Shannon Grant
• Companies: Axio Research Inc. and and Axio Research Inc.
• Keywords: Data Monitoring Committees ; DMCs

Abstract

Data Monitoring Committees (DMCs) are now standard for many clinical studies. A DMC meets regularly during the course of the study and reviews results by arm to ensure the study is still ethical to continue by focusing on protecting the safety of trial participants, the credibility of the study, and the validity of study results.

We would like to share our insights into what distinguishes an effective DMC report from an ineffective one. Because DMC members have a limited time to review the report prior to the DMC meeting, the tables, listings, and figures (TLFs) should be designed to focus on key safety or efficacy signals as briefly as possible.

There are also aspects of DMC monitoring that are related to the real-time nature of reviewing a live database where the data may not have been entered or fully cleaned. The DMC should be provided current data, and metrics are shown to help assess the level of data collection.

We present our suggested Table of Contents for a 100-page DMC Report with examples of the TLFs that we think give the DMC the essential information for their review, without unnecessary reports that would distract from the DMC's primary responsibilities.