一份数据监测经验的病例报告：夜间氧疗试验。

A case report of data monitoring experience: the nocturnal oxygen therapy trial.

作者信息

DeMets D L, Williams G W, Brown B W

出版信息

Control Clin Trials. 1982 Jun;3(2):113-24. doi: 10.1016/0197-2456(82)90039-3.

Abstract

The monitoring of accumulating data in a clinical trial is a challenging endeavor, yet one that must be undertaken to fulfill the ethical responsibility to the participating subject. This paper, using the Nocturnal Oxygen Therapy Trial as an example, discusses three issues often faced by data monitoring committees. These are (1) the multiplicity of outcomes, (2) decisions about extension of the patient recruitment period in order to achieve specified sample size goals, and (3) problems in monitoring survival data with a lag in the reporting of events. The decision process can be quite complex and existing statistical methodology can at best serve as a guide in this decision process.

摘要

在临床试验中监测不断积累的数据是一项具有挑战性的工作，但这是为履行对参与试验的受试者的伦理责任而必须开展的工作。本文以夜间氧疗试验为例，讨论了数据监测委员会经常面临的三个问题。这些问题包括：（1）结果的多样性；（2）关于延长患者招募期以实现特定样本量目标的决策；（3）在事件报告存在延迟的情况下监测生存数据时遇到的问题。决策过程可能相当复杂，现有的统计方法充其量只能在这个决策过程中起到指导作用。