Modern Ideas of Better DMC Report

• Activity Number: 372
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Yao Yao* and David Kerr and Tingting Li and Kent Koprowicz
• Companies: Axio Research and Axio Research and Axio Research and Axio Research
• Keywords: Data Monitoring Commitee ; Statistical report

Abstract

Data Monitoring Committees (DMCs) have been in operation for decades as a means to help ensure that ongoing studies are safe and ethical to continue as well as to provide extra protection of the scientific integrity and clinical value of the trial. However there continue to be ideas (some that are controversial) which could improve the DMC process but have not yet been implemented for all DMCs - improvements specifically tailored to serve DMC. A DMC favored statistical output is not a subset of Final Study Report (FSR). It usually contains ~20 Tables, Listings and Figures based on "current" but not perfectly "cleaned" data. In addition to Safety, a typical DMC report also includes summaries of "study conduct", e.g., Figure of observed vs. expected enrollment over time to allow assessment for whether accrual will finish in a reasonable amount of time; Summary of time overdue for next expected visit, or time from last visit to clinical cut-off date; Summary of number of records expected vs. received at each visit and etc. This poster will focus on what a DMC favored statistical output look like and examples of DMC unique Tables and Figures will be provided.