How to Organize a Data Monitoring Committee and Prepare an Optimal Data Package?

• Activity Number: 402
• Type: Topic Contributed
• Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Vipin K. Arora*+ and David Manner
• Companies: Eli Lilly and Company and Southwestern Medical School
• Keywords: data monitoring committee ; data analysis group ; best practices

Abstract

The FDA draft guidance document, "On the Establishment and Operation of Clinical Trial Data Monitoring Committees," provides insight on organizing a data monitoring committee (DMC); however, the actual implementation of a DMC can become a challenging experience for statisticians. Some of challenges may include: identifying therapeutic area (TA) experts, selecting a chairperson, logistics of DMC meetings, protecting bias by arranging an independent data analysis group (DAG), unblinding process, and finalizing DMC charter. The statistician has key responsibility of collaborating with the DMC chairperson and finalize list of reports that are shared at each DMC meeting. An optimal data package is key to enable DMC to make an accurate assessment. Thorough discussions on TA, Protocol, and SAP must occur between the sponsor statistician and DAG to enable DAG to prepare responses to questions at the DMC meeting. In theory, SAP can cover all analyses that are executed by DAG. In practice, however, this arrangement can result in a situation wherein few key questions raised by DMC go unanswered due to lack of all background information within DAG.