Cartwright, Michael, Friede, Tim, Lawrence, David, May, Emma, Muetze, Tobias and Roes, Kit (2024) Stakeholder perspective on current issues in Data Monitoring Committees. Biometrical Journal, 66 (7). ISSN 0323-38471521-4036

Abstract

A Data Monitoring Committee (DMC) is a group of experts that reviews accumulating data from one or more ongoing clinical trials on a regular basis. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. While DMCs are widely used considerable variability exists in how DMCs are conducted. This paper offers practical recommendations, derived from the 2023 PSI and CEN Conferences' interactive workshops, to enhance DMCs’ operations and performance. We will focus on a number of topics that are part of the DMC process and where there is unclarity and inconsistency. This paper focuses on four key areas that can significantly impact DMC performance and impact, and where there is inconsistency in current practices: 1) 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. 2) Communication with the DMC: We reflect on the importance of effective and proper communication channels between the DMC and relevant stakeholders, including sponsors, investigators, and regulatory authorities, to foster collaboration and exchange of critical information, whilst retaining study integrity throughout. 3). Access to efficacy data: we highlight the need for timely and 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 innovative and interactive data displays to facilitate more intuitive interpretation and understanding of study results by the DMC. By addressing these specific topics, we aim to provide comprehensive practical recommendations that bridge the gap between current practices and optimal DMC functionality.

Item Type:	Article
Keywords:	Data monitoring committee, Patient safety, Trial integrity, benefit-risk
Date Deposited:	05 Oct 2024 00:45
Last Modified:	05 Oct 2024 00:45
URI:	https://oak.novartis.com/id/eprint/52632