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An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia.

机译：第二代抗精神病药治疗精神分裂症的随机临床试验中资金来源的效果分析。

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OBJECTIVE: The effect of funding source on the outcome of randomized controlled trials has been investigated in several medical disciplines; however, psychiatry has been largely excluded from such analyses. In this article, randomized controlled trials of second generation antipsychotics in schizophrenia are reviewed and analyzed with respect to funding source (industry vs. non-industry funding). METHOD: A literature search was conducted for randomized, double-blind trials in which at least one of the tested treatments was a second generation antipsychotic. In each study, design quality and study outcome were assessed quantitatively according to rating scales. Mean quality and outcome scores were compared in the industry-funded studies and non-industry-funded studies. An analysis of the primary author's affiliation with industry was similarly performed. RESULTS: Results of industry-funded studies significantly favored second generation over first generation antipsychotics when compared to non-industry-funded studies. Non-industry-funded studies showed a trend toward higher quality than industry-funded studies; however, the difference between the two was not significant. Also, within the industry-funded studies, outcomes of trials involving first authors employed by industry sponsors demonstrated a trend toward second generation over first generation antipsychotics to a greater degree than did trials involving first authors employed outside the industry (p=0.05). CONCLUSIONS: While the retrospective design of the study limits the strength of the findings, the data suggest that industry bias may occur in randomized controlled trials in schizophrenia. There appears to be several sources by which bias may enter clinical research, including trial design, control of data analysis and multiplicity/redundancy of trials.
机译：目的：已经在多个医学学科中研究了资金来源对随机对照试验结果的影响。但是，精神病学基本上没有被纳入此类分析。在本文中，就精神分裂症的第二代抗精神病药进行了随机对照试验，并就资金来源（行业与非行业资金）进行了分析。方法：对随机，双盲试验进行了文献检索，其中至少一种被测治疗是第二代抗精神病药。在每项研究中，根据评级量表对设计质量和研究结果进行了定量评估。在行业资助的研究和非行业资助的研究中比较了平均质量和结果得分。对主要作者与行业的隶属关系进行的分析也类似。结果：与非行业资助的研究相比，行业资助的研究结果明显优于第二代抗精神病药。非工业研究显示出比工业研究更高的质量趋势。但是，两者之间的差异并不明显。同样，在行业资助的研究中，涉及行业赞助商的第一作者的试验结果表明，与第一代抗精神病药相比，第二代药物的趋势要比在行业之外雇用第一作者的试验更大（p = 0.05）。结论：尽管这项研究的回顾性设计限制了研究结果的强度，但数据表明，在精神分裂症的随机对照试验中可能会出现行业偏见。偏差可能会通过多种来源进入临床研究，包括试验设计，数据分析控制和试验的多重性/冗余性。

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