Departamento de Economía, Universitat Rovira i Virgili, Spain.
J Health Econ. 2009 Dec;28(6):1141-53. doi: 10.1016/j.jhealeco.2009.08.004. Epub 2009 Aug 27.
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.
制药公司有选择性地报告临床试验结果的丑闻，凸显了临床试验需要提高透明度。我们提供了一个理论框架，该框架再现了选择性报告的激励因素，并对监管产生了三个关键影响。首先，强制性临床试验注册处可以通过自愿临床试验结果数据库进行补充，从而实现完全透明（所有试验及其结果都已知）。其次，完全透明是有代价的。它对进行临床试验的激励产生了威慑作用，因为它减少了公司从试验中获得的收益。第三，原则上，没有强制性注册处的自愿临床试验结果数据库是一个更好的监管工具；但是，当医疗决策者不能正确预测制药公司是否进行试验的决定时，我们为额外的强制性注册处提供了一些有条件的支持。
