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Trials, tricks and transparency: How disclosure rules affect clinical knowledge

机译:试验,技巧和透明度:披露规则如何影响临床知识

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摘要

Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined the need for more transparency in clinical trials. We provide a theoretical framework which reproduces incentives for selective reporting and yields three key implications concerning regulation. First, a compulsory clinical trial registry complemented through a voluntary clinical trial results database can implement full transparency (the existence of all trials as well as their results is known). Second, full transparency comes at a price. It has a deterrence effect on the incentives to conduct clinical trials, as it reduces the firms' gains from trials. Third, in principle, a voluntary clinical trial results database without a compulsory registry is a superior regulatory tool; but we provide some qualified support for additional compulsory registries when medical decision-makers cannot anticipate correctly the drug companies' decisions whether to conduct trials.
机译:制药公司选择性报告临床试验结果的丑闻凸显了在临床试验中提高透明度的必要性。我们提供了一个理论框架,再现了选择性报告的动机,并产生了与监管有关的三个关键含义。首先,强制性临床试验注册中心辅以自愿的临床试验结果数据库可以实现完全透明(所有试验的存在及其结果都是已知的)。第二,完全透明是有代价的。它对进行临床试验的动机具有威慑作用,因为它减少了公司从试验中获得的收益。第三,原则上,没有强制性注册的自愿临床试验结果数据库是一种出色的监管工具;但是,当医疗决策者无法正确预测药物公司是否进行试验的决定时,我们会为其他强制性注册提供合格的支持。

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