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

<b>Background:</b> 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. <b>Methods:</b> 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. <b>Outcome measures and results:</b> 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. <b>Conclusions:</b> 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.

<b>研究背景：</b>本研究旨在评估2014年期间获欧洲药品管理局（European Medicines Agency, EMA）批准的所有新药相关企业赞助临床试验的结果及时披露情况。本研究是三项既往已发表研究的最终延伸研究，这三项研究分别针对2009年、2010年、2011年以及2012年、2013年在欧洲获批的所有新药相关临床试验展开。初始研究显示，在为期三年的观察周期内，超四分之三的临床试验结果在试验完成后12个月内完成披露，且截至研究结束（2013年1月31日）时，近90%的试验结果已完成披露。针对2012年、2013年获批新药的两项延伸研究均显示，12个月内结果披露率提升至90%，且研究结束时的整体披露率分别达到92%与93%。<b>研究方法：</b>本研究采用的方法与既往研究完全一致。通过检索各类公开信息源，获取临床试验注册与结果披露相关信息。本研究纳入所有针对2014年获EMA批准上市的新药、以患者为研究对象、已在临床试验注册平台登记且/或收录于EMA欧洲公共评估报告（European Public Assessment Report, EPAR）的已完成企业赞助临床试验。信息检索工作于2016年5月1日至7月31日期间完成。<b>结局指标与研究结果：</b>本研究的主要结局指标为，临床试验结果在首次监管批准或试验完成两者中较晚日期的12个月内，或截至2016年7月31日（本研究调查结束日）时，已在注册平台或学术文献中完成披露的试验占比。在2014年获22家不同企业授权上市的32种新药相关的已完成临床试验中，93%（505/542）的试验结果在12个月内完成披露，且截至2016年7月31日时，96%（518/542）的试验结果已完成披露。<b>研究结论：</b>12个月内93%的结果披露率表明，企业赞助临床试验的结果仍在保持及时披露。本研究结束时96%的整体披露率则说明，针对2014年获批新药的相关临床试验中，企业赞助试验的透明度提升态势得以维持。