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制药公司资金与临床精神病学研究结果之间的关系。

Relationship between drug company funding and outcomes of clinical psychiatric research.

作者信息

Kelly Robert E, Cohen Lisa J, Semple Randye J, Bialer Philip, Lau Adam, Bodenheimer Alison, Neustadter Elana, Barenboim Arkady, Galynker Igor I

机构信息

Department of Psychiatry, Beth Israel Medical Center, New York, NY 10003, USA.

出版信息

Psychol Med. 2006 Nov;36(11):1647-56. doi: 10.1017/S0033291706008567. Epub 2006 Aug 8.

Abstract

BACKGROUND

Pharmaceutical industry funding of psychiatric research has increased significantly in recent decades, raising the question of a relationship between pharmaceutical company funding of clinical psychiatric studies and the outcomes of those studies. This study examines this relationship.

METHOD

Abstracts of articles from 1992 and 2002 in four peer-reviewed psychiatric journals were examined. Drug outcomes (n=542) for clinical studies were evaluated and then compared across sponsorship source. Outcome raters were blind to source of sponsorship. The percentage of these studies sponsored by drug companies in 2002 v. 1992 was also compared. In a secondary analysis, the contribution of a series of potentially mediating variables to the relationship between sponsorship source and study outcome was assessed via logistic regression.

RESULTS

The percentage of studies sponsored by drug companies increased from 25% in 1992 to 57% in 2002. Favorable outcomes were significantly more common in studies sponsored by the drug manufacturer (78%) than in studies without industry sponsorship (48%) or sponsored by a competitor (28%). These relationships remained after controlling for the effects of journal, year, drug studied, time since FDA drug approval, diagnosis, sample size, and selected study design variables.

CONCLUSIONS

These data indicate an association between pharmaceutical industry funding of clinical studies and positive outcomes of those studies. Further research is needed to elucidate the mechanisms underlying this relationship.

摘要

背景

近几十年来,制药行业对精神科研究的资助显著增加,这引发了制药公司对临床精神科研究的资助与这些研究结果之间关系的问题。本研究对这种关系进行了考察。

方法

对1992年和2002年四种同行评审的精神科期刊上文章的摘要进行了检查。对临床研究的药物结果(n = 542)进行了评估,然后按资助来源进行了比较。结果评估者对资助来源不知情。还比较了2002年与1992年由制药公司资助的这些研究的百分比。在二次分析中,通过逻辑回归评估了一系列潜在中介变量对资助来源与研究结果之间关系的贡献。

结果

由制药公司资助的研究百分比从1992年的25%增至2002年的57%。在由制药商资助的研究中,有利结果(78%)比无行业资助的研究(48%)或由竞争对手资助的研究(28%)显著更为常见。在控制了期刊、年份、所研究药物、自美国食品药品监督管理局药物批准后的时间、诊断、样本量和选定的研究设计变量的影响后,这些关系依然存在。

结论

这些数据表明制药行业对临床研究的资助与这些研究的积极结果之间存在关联。需要进一步研究以阐明这种关系背后的机制。

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