Implementing Registries and Results Databases of Clinical Trials: Is There a Side Effect?

with P González and N Porteiro, Expert Review of Pharmacoeconomics & Outcomes Research, 2010, DOI

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.