Walters L
Kennedy Institute of Ethics, Georgetown University, Washington, D.C. 20057.
Stat Med. 1993 Mar;12(5-6):575-80; discussion 581-2.
Since data monitoring committees (DMCs) began to be established in the 1970s, they have reviewed the clinical outcome data emerging from ongoing trials. The thesis of this essay is that DMCs most effectively promote the validity and credibility of randomized clinical trials when they perform this function with the maximum feasible independence. The essay argues that four types of individuals and groups should be excluded from the interim monitoring of outcome data: (1) investigators entering patients into a trial; (2) principal investigators or study chairs; (3) representatives of commercial firms connected with a trial; and (4) representatives of regulatory agencies. The role of statistical groups and officials of government funding agencies in the review of outcome data is also discussed.
自20世纪70年代开始设立数据监测委员会（DMC）以来，这些委员会一直在审查正在进行的试验所产生的临床结果数据。本文的论点是，当数据监测委员会以最大可行的独立性履行这一职能时，它们能最有效地提高随机临床试验的有效性和可信度。本文认为，有四类个人和团体应被排除在结果数据的中期监测之外：（1）将患者纳入试验的研究人员；（2）主要研究人员或研究负责人；（3）与试验相关的商业公司代表；（4）监管机构代表。文中还讨论了统计小组和政府资助机构官员在审查结果数据方面的作用。
