Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014

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 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies.

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 2014, 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 2016.

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 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016.

Conclusions: The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2014.

Keywords:

• Clinical trials
• publication bias
• results disclosure
• transparency
• trial registration
• trial registries
• trial publication

Transparency

Declaration of funding

Publication support for this study was funded by the Association of the British Pharmaceutical Industry (ABPI). The ABPI represents the UK-based biopharmaceutical industry.

Author contributions: S.P. critically revised the manuscript for important intellectual content and contributed to the interpretation of the data. The study was carried out by B.R.D. and two medical information specialists from Livewire Communications.

Declaration of financial/other relationships

S.P. has disclosed that she is Interim Executive Director of Research, Medical & Innovation at the ABPI, and Director of Actaros Consultancy Ltd and the MedicoMarketing Partnership. B.R.D. has disclosed that he is a freelance consultant in Pharmaceutical Marketing and Communications.

A CMRO reviewer on this manuscript is a full-time employee of Johnson & Johnson. All other CMRO reviewers have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank the Board of Management of the ABPI for supporting the conduct of the study. Belen Granell Villen (ABPI) assisted with the identification of contacts and communication with MAHs. Paul Basset 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 (R.L.) and Alex Morrison from Livewire Communications assisted with the research. R.L. provided editorial support for the manuscript.