Deane Bryan R, Sivarajah Jacintha
a Livewire Editorial Communications , Gerrards Cross , Bucks , UK.
b Association of the British Pharmaceutical Industry , London , UK.
Curr Med Res Opin. 2017 Mar;33(3):473-478. doi: 10.1080/03007995.2016.1263612. Epub 2017 Jan 7.
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 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. 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. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study.
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 2013, 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 2015.
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 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015.
The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2013.
本研究的目的是评估2013年期间欧洲药品管理局（EMA）批准的所有新药相关的公司资助临床试验结果的及时披露情况。这是之前两项关于2009年、2010年、2011年以及2012年在欧洲批准的所有新药相关试验研究的扩展。原始研究发现，在三年时间里，超过四分之三的试验在12个月内披露，近90%在研究结束时披露。扩展研究（2012年批准情况）显示，12个月内结果披露率提高到90%，研究结束时总体披露率为92%。
所使用的方法与之前报告的完全相同。搜索了各种公开可用的信息来源，以获取临床试验注册和结果披露情况。纳入了所有与2013年EMA批准上市的每种新药相关的已完成的公司资助试验，这些试验在患者中进行，并记录在临床试验登记处和/或包含在EMA欧洲公共评估报告（EPAR）中。于2015年5月1日至7月31日期间搜索信息来源。
主要结果指标是在首次监管批准或试验完成二者中较晚时间点起的12个月内，或在2015年7月31日（调查结束）之前，在登记处或科学文献中披露结果的试验比例。在与2013年授权给24家不同公司的34种新药相关的已完成试验中，90%（484/539） 的试验结果在12个月内披露，93%（500/539） 的试验结果在2015年7月31日之前披露。
12个月内90%的披露率表明行业仍在继续及时进行披露。研究结束时93%的总体披露率表明，在与2013年批准的新药相关的试验中，公司资助试验的透明度提高情况得以保持。
