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精神病学临床试验报告中的行业赞助与利益冲突

Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry.

作者信息

Perlis Roy H, Perlis Clifford S, Wu Yelena, Hwang Cindy, Joseph Megan, Nierenberg Andrew A

机构信息

Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.

出版信息

Am J Psychiatry. 2005 Oct;162(10):1957-60. doi: 10.1176/appi.ajp.162.10.1957.

DOI:10.1176/appi.ajp.162.10.1957
PMID:16199844
Abstract

OBJECTIVE

Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge.

METHOD

The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003.

RESULTS

Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies.

CONCLUSIONS

Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.

摘要

目的

据报道,利益冲突在普通医学临床试验中普遍存在,并且与报告有利于所研究干预措施的结果的可能性更大相关。据作者所知,精神科临床试验中行业资助和利益冲突的程度及影响尚未得到研究。

方法

作者调查了2001年至2003年间发表在《美国精神病学杂志》《普通精神病学档案》《临床精神药理学杂志》和《临床精神病学杂志》上的所有临床试验的资金来源和作者利益冲突情况。

结果

在确定的397项临床试验中,239项(60%)报告接受了制药公司或其他相关方的资助,187项研究(47%)至少有一名作者报告存在利益冲突。在162项随机、双盲、安慰剂对照研究中,报告存在利益冲突的研究报告阳性结果的可能性高4.9倍;这种关联仅在制药行业资助的研究子集中显著。

结论

作者利益冲突在精神科临床试验中似乎普遍存在,并且与报告药物优于安慰剂的可能性更大相关。

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