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临床试验的资金来源与结果

Source of funding and outcome of clinical trials.

作者信息

Davidson R A

出版信息

J Gen Intern Med. 1986 May-Jun;1(3):155-8. doi: 10.1007/BF02602327.

Abstract

Because of recent concerns about conflicts of interest and published research, the author analyzed 107 controlled clinical trials. Studies were classified as favoring either a new therapy or a traditional therapy, and as being supported by a pharmaceutical manufacturer or as being generally supported. Seventy-one per cent of the trials favored new therapies; 43% of these were funded by pharmaceutical firms. Of the 31 trials favoring traditional therapy, only four (13%) were supported by a pharmaceutical firm. There was a statistically significant association between the source of funding and the outcome of the study (p = 0.002). Few trials supported by pharmaceutical manufacturers favored traditional therapy; some reasons for this finding may include selection of drugs likely to be proven efficacious, Type II errors (false-negative studies), and fear of discontinuation of funding should such studies be submitted. Important clinical information may be lost if negative studies are not published.

摘要

由于近期对利益冲突和已发表研究的关注,作者分析了107项对照临床试验。研究被分类为支持新疗法或传统疗法,以及由制药商资助或普遍支持。71%的试验支持新疗法;其中43%由制药公司资助。在支持传统疗法的31项试验中,只有4项(13%)由制药公司资助。资金来源与研究结果之间存在统计学上的显著关联(p = 0.002)。由制药商资助的试验中很少有支持传统疗法的;这一发现的一些原因可能包括选择可能被证明有效的药物、II型错误(假阴性研究),以及担心提交此类研究时资金会中断。如果阴性研究未发表,重要的临床信息可能会丢失。

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