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A survey of monitoring practices in cancer clinical trials

机译：癌症临床试验监测实践调查

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AbstractThis paper reports the results of a survey of data monitoring practices of the 12 clinical co‐operative groups in cancer sponsored by the National Cancer Institute in the United States. Most of these co‐operative groups conduct a large number of active clinical trials in a wide variety of cancers. The number of active phase III trials in 1991 was 244 with nearly 24,000 patients entered on these trials. The survey instrument used in this paper was modified from one originally developed by Geller and Stylianou,1supplemented by questions on the responsibilities of data monitoring committees based on Hawkins.2Topics covered included general policies and procedures on the monitoring of clinical trials in these groups as well as specific questions on the responsibilities and operational procedures of formal data monitoring committees. Although formal statistical stopping rules are almost always employed in cancer trials in these co‐operative groups, use of a formal data monitoring committee is a relatively new, but increasing practice. For a variety of economic and practical reasons, the members of data monitoring committees for cancer trials are rarely independent of the study partici
机译：摘要本文报告了美国国家癌症研究所赞助的12个癌症临床合作小组的数据监测实践调查结果。这些合作团体中的大多数在各种癌症中进行了大量积极的临床试验。1991 年正在进行的 III 期试验数量为 244 项，近 24,000 名患者参加了这些试验。本文中使用的调查工具是从最初由 Geller 和 Stylianou 开发的调查工具修改而来的，1 补充了基于 Hawkins 的数据监测委员会的责任问题.2 涵盖的主题包括监测这些小组临床试验的一般政策和程序，以及关于正式数据监测委员会的职责和操作程序的具体问题。尽管在这些合作小组的癌症试验中几乎总是采用正式的统计停止规则，但使用正式的数据监测委员会是一种相对较新但越来越多的做法。由于各种经济和实际原因，癌症试验数据监测委员会的成员很少独立于研究参与者

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