DeMets David L, Wittes Janet
University of Wisconsin-Madison, Madison, WI, USA.
WCG Acquires Statistics Collaborative, Washington, DC, USA.
Clin Trials. 2022 Feb;19(1):107-111. doi: 10.1177/17407745211051279. Epub 2021 Oct 24.
Currently, too many Data Monitoring Committee Reports for interim review of trial progress are quite inadequate for Data Monitoring Committees to make informed decisions about risks and benefits. Immediate serious improvement is necessary for Data Monitoring Committees to meet their ethical, clinical, and scientific responsibility to trial participants, investigators, sponsors, and participating institutions. To achieve this critical goal, all parties involved in the Data Monitoring Committee process including sponsors, investigators, Data Monitoring Committee members, and the independent statistical reporting group need to have a better understanding of the structure, function, and needs of a Data Monitoring Committee and the content of a Data Monitoring Committee Report. Training modules through the Society for Clinical Trials are now available on their website to facilitate this.
目前，太多用于试验进展中期审查的数据监测委员会报告相当不充分，以至于数据监测委员会无法就风险和益处做出明智的决策。数据监测委员会要履行其对试验参与者、研究者、申办者和参与机构的伦理、临床和科学责任，必须立即进行重大改进。为实现这一关键目标，参与数据监测委员会流程的所有各方，包括申办者、研究者、数据监测委员会成员和独立统计报告小组，都需要更好地了解数据监测委员会的结构、职能和需求，以及数据监测委员会报告的内容。临床试验协会现已在其网站上提供培训模块以促进这一点。
