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行业资助的比较精神药理学试验中的设计与报告变更

Design and reporting modifications in industry-sponsored comparative psychopharmacology trials.

作者信息

Safer Daniel J

机构信息

Departments of Psychiatry and Pediatrics, Johns Hopkins University School of Medicine, Baltimore, 7702 Dunmanway, Dundalk, MD 21222, USA.

出版信息

J Nerv Ment Dis. 2002 Sep;190(9):583-92. doi: 10.1097/00005053-200209000-00002.

Abstract

This review of recently published pharmaceutical industry-sponsored comparative psychotropic drug trials aims to classify apparent design and reporting modifications that favor the sponsor's product. The modifications have been grouped into 13 discrete categories, and representative examples of each are presented. Strong circumstantial evidence suggests that marketing goals led to these adjustments. The consequences of marketing influences on comparative psychopharmacology trials are discussed in terms of conflicts of interest, the integrity of the scientific literature, and costs to consumers, as well as their impact on physician practice.

摘要

这篇对近期发表的由制药行业资助的精神类药物对比试验的综述,旨在对那些有利于赞助商产品的明显设计和报告修改进行分类。这些修改被归为13个不同类别,并给出了每类的代表性例子。有力的间接证据表明,营销目标导致了这些调整。从利益冲突、科学文献的完整性、消费者成本以及对医生执业的影响等方面,讨论了营销影响对精神药理学对比试验的后果。

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