临床试验中的P-黑客行为及激励机制如何影响分布 各阶段的结果

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摘要翻译：
鉴于人命关天，临床研究应符合道德和科学诚信的高标准。然而，经济激励可能会给调查人员带来利益冲突，他们可能倾向于隐瞒不利的结果，甚至篡改数据，以实现预期的结果。为了揭示临床试验结果的完整性，本文系统地分析了向Clinicaltrials.gov注册中心报告的II期和III期药物试验主要结果的P值分布。首先，我们没有检测到结果的聚类刚好高于经典的5%的统计显著性阈值。其次，密度不连续性测试显示，小型行业赞助商的第三阶段结果在5%的阈值上向上跃升。第三，与第二阶段相比，我们在第三阶段记录了更多的重要结果。将跨阶段的试验联系起来，我们发现早期有利的结果增加了继续进入下一阶段的可能性。一旦我们考虑到这种选择性的延续，我们就可以几乎完全解释大型工业赞助商在第三阶段进行的试验中大量的重要结果。相反，对于小型行业赞助商来说，部分超额仍无法解释。
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英文标题：
《P-hacking in clinical trials and how incentives shape the distribution
  of results across phases》
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作者：
J\'er\^ome Adda, Christian Decker, Marco Ottaviani
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最新提交年份：
2020
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分类信息：

一级分类：Economics        经济学
二级分类：General Economics        一般经济学
分类描述：General methodological, applied, and empirical contributions to economics.
对经济学的一般方法、应用和经验贡献。
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一级分类：Quantitative Finance        数量金融学
二级分类：Economics        经济学
分类描述：q-fin.EC is an alias for econ.GN. Economics, including micro and macro economics, international economics, theory of the firm, labor economics, and other economic topics outside finance
q-fin.ec是econ.gn的别名。经济学，包括微观和宏观经济学、国际经济学、企业理论、劳动经济学和其他金融以外的经济专题
--

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英文摘要：
  Clinical research should conform to high standards of ethical and scientific integrity, given that human lives are at stake. However, economic incentives can generate conflicts of interest for investigators, who may be inclined to withhold unfavorable results or even tamper with data in order to achieve desired outcomes. To shed light on the integrity of clinical trial results, this paper systematically analyzes the distribution of p-values of primary outcomes for phase II and phase III drug trials reported to the ClinicalTrials.gov registry. First, we detect no bunching of results just above the classical 5% threshold for statistical significance. Second, a density discontinuity test reveals an upward jump at the 5% threshold for phase III results by small industry sponsors. Third, we document a larger fraction of significant results in phase III compared to phase II. Linking trials across phases, we find that early favorable results increase the likelihood of continuing into the next phase. Once we take into account this selective continuation, we can explain almost completely the excess of significant results in phase III for trials conducted by large industry sponsors. For small industry sponsors, instead, part of the excess remains unexplained.
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PDF链接：
https://arxiv.org/pdf/1907.00185

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关键词：激励机制 临床试验 distribution Investigator Continuation 行业 clinical 调查 incentives 测试