Parexel International Ltd., Sheffield, UK.
Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
Biom J. 2024 Oct;66(7):e202300384. doi: 10.1002/bimj.202300384.
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.
数据监测委员会（DMC）是一组专家，负责审查来自一项或多项正在进行的临床研究的累积数据，并就研究对象的持续安全性以及研究的持续有效性和科学价值向赞助商提供建议。尽管 DMC 被广泛使用，但它们的运作方式存在很大的差异。本文提供了一些建议，这些建议源自于 2023 年中欧网络国际制药行业生物统计学家会议上的演讲和作者的经验。我们重点关注了四个在 DMC 流程中存在不明确和不一致的话题：（1）与 DMC 的沟通——我们反思了 DMC 与相关利益相关者之间进行有效、适当沟通的重要性，以促进协作和关键信息的交流，同时保持研究的完整性。（2）公开会议——我们讨论了在 DMC 会议中纳入公开会议的好处，以提高透明度、包容性和考虑不同观点，并探讨了公开会议的潜在陷阱。（3）疗效数据的获取——我们强调了 DMC 适当获取疗效数据的必要性，并讨论了如何在实践中实施这一点，以及如何解决与多重性相关的潜在问题。（4）交互式数据展示——我们概述了如何利用交互式数据展示来促进 DMC 更直观地理解研究结果。通过解决这些问题，我们旨在提供全面的实用建议，弥合当前实践与最佳 DMC 功能之间的差距。
