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[临床试验中的方法学缺陷]

[Methodological deficiencies in clinical trials].

作者信息

Nahler G

机构信息

Clinical Investigation Support Pharmaforschung GmbH & Co. KG, Wien.

出版信息

Fortschr Med. 1992 Oct 10;110(28):511-4.

PMID:1398408
Abstract

In many cases, the results obtained with clinical trials are out of all proportion to the time, money and effort invested by those participating in them. The reasons for this are to be sought, for the most part, in readily avoidable errors at the planning stage, during evaluation and during preparation for publication. Common weak points prove to be the design of the trial, patient numbers, selection of end points, characteristics of case material, blinding, randomization, exclusion from evaluation, test efficiency (power 1-beta), subgroup analyses and interim analyses.

摘要

在许多情况下,临床试验所获得的结果与参与试验者投入的时间、金钱和精力极不相称。究其原因,大部分要归咎于在试验规划阶段、评估阶段以及发表准备阶段极易避免的错误。常见的薄弱环节包括试验设计、患者数量、终点选择、病例材料特征、盲法、随机化、排除在评估之外、检验效能(把握度1-β)、亚组分析和期中分析。

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