1 Department of Biostatistics, University of Washington, Seattle, WA, USA.
2 University of Pennsylvania, Philadelphia, PA, USA.
Clin Trials. 2018 Aug;15(4):321-328. doi: 10.1177/1740774518764855. Epub 2018 Apr 9.
Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials. Even with the wide recognition of these principles, there are circumstances where confidentiality issues remain challenging, controversial or inconsistently addressed. First, consider settings where a clinical trial's interim data could provide the evidence regulatory authorities require for decisions about marketing approval, yet where such a trial would be continued post-approval to provide more definitive evidence about principal safety and/or efficacy outcomes. In such settings, data informative about the longer term objectives of the trial should remain confidential until pre-specified criteria for trial completion have been met. Second, for those other than Data Monitoring Committee members, access to safety and efficacy outcomes during trial conduct, even when presented as data pooled across treatment arms, should be on a limited "need to know" basis relating to the ability to carry out ethical or scientific responsibilities in the conduct of the trial. Third, Data Monitoring Committee members should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits. Fourth, it should be recognized that a mediator potentially could be useful in rare settings where the Data Monitoring Committee would have serious ethical or scientific concerns about the sponsor's dissemination or lack of dissemination of information. Data Monitoring Committee Contract Agreements, Indemnification Agreements and Charters should be developed in a manner to protect Data Monitoring Committee members and their independence, in order to enhance the Data Monitoring Committee's ability to effectively address their mission.
维护新兴数据的机密性并确保数据监测委员会的独立性，是这些委员会实现其保护研究参与者利益和增强临床试验完整性和可信度使命的重要实践。即使这些原则得到广泛认可，但在某些情况下，保密性问题仍然具有挑战性、存在争议或处理不一致。首先，考虑这样的情况，即临床试验的中期数据可以为监管机构提供有关营销批准的决策所需的证据，但在批准后，该试验将继续进行，以提供关于主要安全性和/或疗效结果的更明确证据。在这种情况下，与满足试验完成的预定标准相关的试验更长期目标的数据应保持机密。其次，对于数据监测委员会成员以外的人员，即使在作为跨治疗臂汇总的数据呈现的情况下，在试验过程中获得安全性和疗效结果的访问权限也应仅限于与执行试验的伦理或科学责任相关的“按需知”基础。第三，数据监测委员会成员应在整个试验过程中获得未盲的疗效和安全性数据，以便能够及时、知情地判断风险和收益。第四，应认识到，在数据监测委员会对赞助商的信息传播或缺乏传播存在严重伦理或科学问题的罕见情况下，调解人可能会有用。应制定数据监测委员会合同协议、赔偿协议和章程，以保护数据监测委员会成员及其独立性，从而增强数据监测委员会有效履行其使命的能力。
