Universitat Rovira i Virgili, Reus, Spain.
Expert Rev Pharmacoecon Outcomes Res. 2010 Jun;10(3):247-51. doi: 10.1586/erp.10.25.
Many parts of the world are currently witnessing a controversial discussion concerning the appropriate design of the environment for clinical trials. The catalyst of this debate has been a number of highly publicized cases in which pharmaceutical firms are accused of having selectively disclosed evidence on marketed drugs. Many participants in the discussion promote greater transparency in clinical trials and support the introduction of mandatory clinical trials registries and results databases. This report draws upon prior work by the authors analyzing the effects of these regulations on a pharmaceutical firm's incentives to conduct clinical trials. Our findings add a new dimension to the discussion since they show the existence of a trade-off - as intended, registries and databases have the potential to increase transparency in clinical trials but they are likely to reduce the incentives to carry out clinical trials. This does not imply that these regulations are undesirable but it underlines the need for more research to be conducted on the incentive effects of these policies, because an informed policy choice must take into account all likely consequences of regulatory action and balance conflicting goals.
目前，世界上许多地区正在就临床试验环境的合理设计展开一场颇具争议的讨论。这场辩论的催化剂是一些备受瞩目的案例，制药公司被指控选择性披露已上市药物的证据。讨论中的许多参与者提倡在临床试验中提高透明度，并支持引入强制性临床试验注册和结果数据库。本报告借鉴了作者之前分析这些法规对制药公司进行临床试验的激励措施的影响的工作。我们的研究结果为讨论增添了新的维度，因为它们表明存在一种权衡——正如预期的那样，注册和数据库有可能提高临床试验的透明度，但它们可能会降低进行临床试验的激励。这并不意味着这些法规不受欢迎，但它强调需要对这些政策的激励效应进行更多的研究，因为明智的政策选择必须考虑到监管行动的所有可能后果，并平衡相互冲突的目标。
