DeMets David L, Fleming Thomas R, Rockhold Frank, Massie Barry, Merchant Thomas, Meisel Alan, Mishkin Barbara, Wittes Janet, Stump David, Califf Robert
University of Wisconsin, Madison, WI, USA.
Clin Trials. 2004;1(6):525-31. doi: 10.1191/1740774504cn54oa.
In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs bear serious responsibility for participant safety, their members may be legally liable for their actions. Despite more than three decades of experiences with DMCs, the issues of liability and indemnification have yet to receive appropriate attention from either government or industry sponsors. In industry-sponsored trials, DMC members are usually asked to sign an agreement delineating their responsibilities and operating procedures. While these agreements may include language on indemnification, such language sometimes protects only the sponsor rather than the DMC members. In government-sponsored trials, there has been even less structure, since typically there are no signed agreements regarding DMC activities. This paper discusses these issues and suggests sample language for indemnification agreements to protect DMC members. This type of language should be included in DMC charters and in all consulting agreements signed by DMC members.
在随机临床试验中，通常会任命一个数据监测委员会（DMC）来审查中期数据，以确定是否有早期的确凿证据表明干预措施对研究参与者有益、无益处或有危害。由于数据监测委员会对参与者的安全负有重大责任，其成员可能要对自己的行为承担法律责任。尽管数据监测委员会已经有三十多年的经验，但责任和赔偿问题尚未得到政府或行业赞助商的适当关注。在行业赞助的试验中，数据监测委员会成员通常会被要求签署一份协议，明确他们的职责和操作程序。虽然这些协议可能包含有关赔偿的条款，但此类条款有时仅保护赞助商，而不是数据监测委员会成员。在政府赞助的试验中，相关架构更少，因为通常没有关于数据监测委员会活动的签署协议。本文讨论了这些问题，并提出了赔偿协议的示例条款，以保护数据监测委员会成员。此类条款应纳入数据监测委员会章程以及数据监测委员会成员签署的所有咨询协议中。
