A study commissioned by the Association of the British Pharmaceutical Industry has found rising levels of disclosure for industry-sponsored clinical trials, although it also shows “more remains to be done”, the ABPI acknowledges.
In the study published by the peer-review journal Current Medical Research and Opinion, 77% of 807 evaluable industry-sponsored clinical trials for new medicines recently approved by the European Medicines Agency (EMA) had some results disclosed within a year of completion or of regulatory approval, the association notes.
Moreover, the study indicates that disclosure rates for industry-sponsored trials have continued to rise, with results available for 89% of these studies by 31 January 2013.
“There are no quick fixes to this global issue, but this research provides an important baseline that identifies where there is still work to be done,” commented ABPI chief executive Stephen Whitehead.
“This study marks an important step, and we fully expect to see the trend towards greater transparency continue on this positive trajectory.”
The study was designed and authored by Bina Rawal, the ABPI’s research, medical and innovation director, and by Bryan Deane, a pharmaceutical consultant working for Livewire Editorial Communications.
The research was carried out by a team of medical-information specialists from Livewire Communications, led by Deane.
Call for evidence
The ABPI initiated the study in light of the “variation in reported disclosure rates, and specifically in response to a call for evidence from the UK’s House of Commons Select Committee on Science and Technology, which announced an inquiry into clinical trials and data disclosure in December 2012.
The study is thought to be the first to assess the proportion of industry-sponsored clinical trials for which at least some results have been publicly disclosed “by searching a range of clinical trial registries and databases, and/or by publication in the scientific literature, without regard to prevailing reporting requirements”, the association says.
The researchers surveyed various publicly available information sources (including clinical trial registries, the International Federation of Pharmaceutical Manufacturers and Associations Clinical Trials Portal, EMA European Public Assessment Reports (EPAR) and PubMed) for both clinical trial registration and results disclosure over the period 27 December 2012 to 31 January 2013.
They identified identified 53 new medicines (new active substances, excluding vaccines and combination products) approved for marketing by the EMA in 2009, 2010 and 2011, and licensed to 34 different companies.
The study covered all completed company-sponsored clinical trials associated with these approved medicines and conducted in patients as well as recorded on a clinical trial registry and/or included in an EPAR.
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 first regulatory approval or of al completion (the later of the two); or by 31 January 2013, marking the end of the survey.
Of the completed and evaluable trials associated with all 53 new medicines approved by the EMA between 2009 and 2011, 77% had results disclosed within 12 months. By 31 January 2013, that figure had increased to 89%, Rawal and Deane reported.
Rates of results disclosure within 12 months were 71%, 81% and 86% respectively for new medicines approved in 2009, 2010 and 2011. Disclosure levels had increased to 86%, 93% and 91% respectively by 31 January 2013.
The timely disclosure of clinical trial results, in accordance with the latest principles of transparency, “is now being implemented to a greater extent by the global pharmaceutical industry than previously reported”, the authors concluded.
“The finding that results of nearly 90% of all company-sponsored trials related to medicines approved in 2009, 2010 and 2011 are now disclosed … is already encouraging, and the increasing commitment of the pharmaceutical industry to transparency in clinical trial reporting should lead to continued improvement in the future,” they added.