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抗抑郁药临床试验中的利益冲突和结果:一项 18 年的回顾性研究。

Conflicts of interest and outcomes of clinical trials of antidepressants: An 18-year retrospective study.

机构信息

CMH Lahore Medical College & Institute of Dentistry, Lahore Cantt., Pakistan.

CMH Lahore Medical College & Institute of Dentistry, Lahore Cantt., Pakistan.

出版信息

J Psychiatr Res. 2019 Sep;116:83-87. doi: 10.1016/j.jpsychires.2019.05.029. Epub 2019 Jun 11.

Abstract

Pharmaceutical sponsorship, funding sources, and investigators' conflicts of interest may be potential influencers in the conduct and results of clinical trials, as well as in the promotion of psychiatric drug therapies. We report the results of an audit of randomized controlled trials (RCTs) of antidepressants conducted from 2000 to 2017. We searched the Web of Science databases with a comprehensive search strategy to identify phase 2 and 3 RCTs. Out of the 1085 articles initially located, a total of 291 RCTs were identified and included in the final analyses. A higher percentage of RCTs conducted by employees of pharmaceutical companies reported favorable results than those with academic or governmental funding (76.90% vs. 60.60%); however, this association was not significant (Χ = 2.47, P = 0.18). The data were further analyzed using bivariate and cluster analytical approaches, and the nonsignificant association persisted in both cases. However, analyses of industry-funded placebo-controlled trials (a subgroup of the 291 RCTs) revealed a higher proportion of results that were reported as significant compared to their counterparts with other funding sources (67% vs. 33%). This association was statistically significant (Χ = 9.56, P = 0.002), indicating that there is evidence in support of conflicts of interest as a potential bias in the outcomes of RCTs conducted for antidepressants.

摘要

制药公司的赞助、资金来源以及研究人员的利益冲突可能会对临床试验的开展和结果产生潜在影响,同时也会对精神类药物治疗的推广产生影响。我们报告了一项对 2000 年至 2017 年期间进行的抗抑郁药随机对照试验(RCT)的审核结果。我们采用全面的搜索策略在 Web of Science 数据库中进行了搜索,以确定 2 期和 3 期 RCT。在最初定位的 1085 篇文章中,共确定了 291 项 RCT 并纳入最终分析。与有学术或政府资金支持的 RCT 相比,由制药公司员工开展的 RCT 报告有利结果的比例更高(76.90% vs. 60.60%);但这种关联并不显著(Χ²=2.47,P=0.18)。使用双变量和聚类分析方法进一步分析数据,在这两种情况下,这种无显著关联都仍然存在。然而,对行业资助的安慰剂对照试验(291 项 RCT 的一个亚组)的分析显示,与其他资金来源相比,报告为显著结果的比例更高(67% vs. 33%)。这种关联具有统计学意义(Χ²=9.56,P=0.002),表明有证据支持利益冲突是抗抑郁药 RCT 结果的潜在偏倚。

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