Novartis Pharma AG, Basel, Switzerland.
Novartis Institutes of Biomedical Research, Cambridge, USA.
Trials. 2023 Apr 21;24(1):289. doi: 10.1186/s13063-023-07290-4.
Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC's workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients.
数据监测委员会（DMC）在进行临床研究期间肩负着保护当前和未来患者安全的重要任务。遗憾的是，由于 DMC 报告结构松散且难以理解，他们的工作常常变得很困难。在本文中，我们提出了改进的解决方案。从原则性的方法出发，并借鉴以前的建议，我们提供了具体且易于理解的显示方式，包括相关的计算机代码。在利用现代工具的同时，最重要的是这些显示方式支持 DMC 回答相关问题的工作流程。我们希望这些建议的采用可以减轻 DMC 的任务，并重要的是，为了患者的利益做出更好的决策。
