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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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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中文摘要：
鉴于人命危在旦夕，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，以达到预期的结果。为了阐明临床试验结果的完整性，本文系统分析了向临床试验报告的II期和III期药物试验主要结果的p值分布。政府注册处。首先，我们没有检测到在统计显著性的经典5%阈值以上的结果聚集。其次，密度不连续性测试显示，小型行业赞助商在第三阶段结果的5%阈值处出现了上升。第三，与第二阶段相比，我们在第三阶段记录了更大比例的重要结果。将各个阶段的试验联系起来，我们发现早期有利的结果增加了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，我们几乎可以完全解释大型行业赞助商进行的试验在第三阶段的显著结果过剩。相反，对于小型行业赞助者来说，部分过剩原因仍无法解释。
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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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