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制药公司资助药物试验及其后果。第 1 部分:对可能影响药物试验结果、方案和质量的文献进行定性、系统的回顾。

The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials.

机构信息

Arzneimittelkommission der deutschen Arzteschaft, Berlin, Germany.

出版信息

Dtsch Arztebl Int. 2010 Apr;107(16):279-85. doi: 10.3238/arztebl.2010.0279. Epub 2010 Apr 23.

Abstract

BACKGROUND

In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This paper provides an overview of the findings of current, systematic studies on this topic.

METHODS

Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.

RESULTS

57 publications were included for evaluation in Parts 1 and 2 of this article. Published drug trials that were financed by pharmaceutical companies, or whose authors declared a financial conflict of interest, were found to yield favorable results for the drug manufacturer more frequently than independently financed trials whose authors had no such conflicts. The results were also interpreted favorably more often than in independently financed trials. Furthermore, there was evidence that pharmaceutical companies influenced study protocols in a way that was favorable to themselves. The methodological quality of trials financed by pharmaceutical companies was not found to be any worse than that of trials financed in other ways.

CONCLUSION

Published drug trials that are financed by pharmaceutical companies may present a distorted picture. This cannot be explained by any difference in methodological quality between such trials and trials financed in other ways.

摘要

背景

近年来,许多研究表明,制药公司资助的临床药物试验往往比独立试验更频繁地为公司产品产生有利的结果。此外,制药公司被发现以各种方式影响药物试验。本文概述了对这一主题的当前系统研究的结果。

方法

从 2002 年 11 月 1 日至 2009 年 12 月 16 日,对这一主题进行了系统的 Medline 搜索,检索到的出版物由两位作者独立评估和选择。这些出版物还补充了其参考文献部分中发现的其他出版物。

结果

在本文的第 1 部分和第 2 部分中,有 57 篇出版物被纳入评估。发现由制药公司资助或作者声明存在财务利益冲突的已发表药物试验,比作者没有此类冲突的独立资助试验更频繁地为药物制造商产生有利结果。这些结果也比独立资助的试验更频繁地被解释为有利。此外,有证据表明制药公司以有利于自己的方式影响研究方案。没有发现制药公司资助的试验的方法学质量比其他方式资助的试验差。

结论

由制药公司资助的已发表药物试验可能会呈现出扭曲的情况。这不能用此类试验与其他方式资助的试验在方法学质量上的差异来解释。

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