Implementing registries and results databases of clinical trials: is there a side effect?

Abstract

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.

Keywords::

• clinical trials
• disclosure rules
• file drawer problem
• pharmaceutical firms
• registries
• results databases
• scientific knowledge
• selective information transmission
• selective reporting

Acknowledgments

The authors very much appreciate the invitation by the Commissioning Editor Morag Robertson to write this report. The authors also wish to thank Elia Belló-Alberola and Amihai Glazer for very useful discussions and encouragement. Comments and suggestions from two anonymous referees have improved the paper considerably.

Financial & competing interests disclosure

Financial support from Fundación Ramón Areces is gratefully acknowledged. This work is also partially supported by the following research projects: projects SEJ-02936 and SEJ-04992 (Junta de Andalucía) and projects ECO2008–04321/ECON and SEJ2007–67580-C02–01 (Spanish Ministry of Education and Science). The views expressed here are those of the authors and may not necessarily reflect the views of the funding institutions. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.