Abstract
Background:
The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2012. This is an extension of the previously reported study of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, which found that over three-quarters of all these trials were disclosed within 12 months and almost 90% were disclosed by the end of the study.
Methods:
The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2012, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2014.
Outcome measures and results:
The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2014 (end of survey). Of the completed trials associated with 23 new medicines licensed to 17 different companies in 2012, results of 90% (307/340) had been disclosed within 12 months, and results of 92% (312/340) had been disclosed by 31 July 2014.
Conclusions:
The disclosure rate within 12 months of 90% suggests the industry is now achieving disclosure in a timely manner more consistently than before. The overall disclosure rate at study end of 92% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2012.
Transparency
Declaration of funding
This study was funded by the Association of the British Pharmaceutical Industry (ABPI). The study was designed by B.R.D. and B.R., and the research carried out by B.R.D. and a medical information specialist from Livewire Communications. The ABPI represents the UK-based biopharmaceutical industry.
Declaration of financial/other relationships
B.R. has disclosed that at the time of the study he was a full time Medical, Innovation and Research Director at the ABPI. B.R.D. has disclosed that he is a freelance consultant in Pharmaceutical Marketing and Communications.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors thank the Board of Management of the ABPI for supporting the conduct of the study. Professor Stephen Send of the Luxembourg Institute of Health advised on the applicability of statistical tests, and performed the time trend analysis. B.R.D. managed the project on behalf of Livewire Communications. Ros Lea from Livewire Communications assisted with the research.