Keywords: data monitoring committee, DMC, DSMB
The Clinical Trials Transformation Initiative Data Monitoring Committees Project, which aimed to 1) describe the current landscape of DMC use and conduct, 2) clarify the purpose of and rationale for using a DMC, 3) identify best practices for independent DMC conduct, 4) describe effective communication practices between independent DMCs and trial stakeholders, during all phases of DMC activity, and 5) identify strategies for preparing a robust pool of DMC members, conducted a survey to assess current use and conduct of DMCs and assess training practices for DMC members and convened focus groups to gain an in-depth understanding of needs and best practices related to DMC use. High level survey and focus group findings will be presented. Based on data gathered via these evidence-gathering activities and feedback from discussion at an expert meeting the project convened, the project team, made up of a diverse group of stakeholder from across the clinical trials enterprise, developed recommendations intended to improve the quality and efficiency of DMCs. The recommendations will be presented and will cover: 1. Role of the DMC, including issues related to DMC access to blinded data and independence; 2. DMC Composition, including issues related to conflict of interest and use of patient advocates in DMCs; 3. Communication related to the DMC, including communication between the DMC, trial sponsor, statistical analysis center, IRBs, and regulatory bodies; 4. DMC Charter, including a sample Table of Contents and points for consideration; and 5. Training DMC members and statistical analysis center statisticians, including suggested training formats and apprenticeship opportunities. Additional tools related to the following will also be presented: 1. Specific responsibilities of the DMC 2. Best practices for conduct of DMC meeting.