Stakeholders' Perspectives on Current Issues in Data Monitoring Committees

• Published in: Biometrical journal Vol. 66; no. 7; pp. e202300384 - n/a
• Main Authors: Cartwright, Michael J., Friede, Tim, Lawrence, David, May, Emma, Mütze, Tobias, Roes, Kit
• Format: Journal Article
• Language: English
• Published: Germany Wiley - VCH Verlag GmbH & Co. KGaA 01.10.2024
• Subjects: benefit‐risk; Biometry - methods; Clinical Trials Data Monitoring Committees; data monitoring committee; Displays; Effectiveness; Humans; Monitoring; patient safety; Pharmaceutical industry; Scientific validity; Stakeholder Participation; study integrity; benefit‐risk; patient safety; data monitoring committee; study integrity
• ISSN: 0323-3847; 1521-4036; 1521-4036
• DOI: 10.1002/bimj.202300384

ABSTRACT Data Monitoring Committees (DMCs) are groups of experts that review accumulating data from one or more ongoing clinical studies and advise the Sponsor regarding the continuing safety of study subjects along with the continuing validity and scientific merit of the study. Although DMCs are widely used, considerable variability exists in their conduct. This paper offers recommendations, derived from sessions given at the 2023 Central European Network International Biometric and Statisticians in the Pharmaceutical Industry Conferences' and the authors' experiences. We focus on four topics that are part of the DMC process and where there is unclarity and inconsistency in current practices: (1) Communication with the DMC—We reflect on the importance of effective, proper communication channels between the DMC and relevant stakeholders to foster collaboration and exchange of critical information while retaining study integrity throughout. (2) Open sessions—We discuss the benefits of incorporating open sessions in DMC meetings to enhance transparency, inclusivity, and the consideration of diverse perspectives, as well as pitfalls of open sessions. (3) Access to efficacy data—We highlight the need for appropriate access to efficacy data by DMCs and discuss how to implement this in practice and how to address potential concerns regarding multiplicity. (4) Interactive data displays—We outline the utilization of interactive data displays to facilitate a more intuitive understanding of study results by the DMC. By addressing these topics, we aim to provide comprehensive practical recommendations that bridge the gap between current practices and optimal DMC functionality.