Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource.
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource.
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DOI：
10.1136/bmj.k3218
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发表时间：
2018-09-12
期刊：
影响因子：
--
通讯作者：
Curtis H
中科院分区：
文献类型：
--
作者：
Goldacre B;DeVito NJ;Heneghan C;Irving F;Bacon S;Fleminger J;Curtis H
确定符合欧盟委员会要求的合规率，即欧盟临床试验注册表（EUCTR）上的所有试验在完成后12个月内将结果发布到注册表（最终合规日期为2016年12月21日）;识别与不合规相关的特征;按合规性对申办者进行排名;并建立一个合规性实时持续审计的工具。回顾性队列研究。EUCTR。在EUCTR上列出的11531项试验中，有7274项已完成，并且结果可以确定为到期。在EUCTR上发表结果。在7274项试验中，49.5%（95%置信区间48.4%至50.7%）报告了结果。与非商业赞助者相比，商业赞助者的试验更有可能公布结果（68.1% v11.0%，校正比值比23.2，95%置信区间19.2 - 28.2）;由进行大量试验的申办者进行的试验也是如此（77.9%对18.4%，调整后比值比18.4，15.3对22.1）。最近的试验更有可能报告结果（每年比值比1.05，95%置信区间1.03至1.07）。在EUCTR数据中发现了大量错误、遗漏和矛盾条目的证据，这些证据妨碍了某些试验的依从性确认。欧盟委员会要求所有试验在完成后12个月内将结果公布到EUCTR，但这一要求的遵守情况很差，一半的试验没有遵守这一要求。欧盟注册数据通常包含不一致性，甚至可能阻止监管机构评估合规性。关于每项试验和申办者依从性状态的清晰和及时的信息可能有助于提高报告率。
To ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance. Retrospective cohort study. EUCTR. 7274 of 11 531 trials listed as completed on EUCTR and where results could be established as due. Publication of results on EUCTR. Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials. Compliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.
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影响因子：
158.5
作者：
Anderson, Monique L.;Chiswell, Karen;Califf, Robert M.
通讯作者：
Califf, Robert M.
影响因子：
105.7
作者：
Prayle, Andrew P.;Hurley, Matthew N.;Smyth, Alan R.
通讯作者：
Smyth, Alan R.
影响因子：
39.2
作者：
Hartung DM;Zarin DA;Guise JM;McDonagh M;Paynter R;Helfand M
通讯作者：
Helfand M
影响因子：
3.7
作者：
Schmucker C;Schell LK;Portalupi S;Oeller P;Cabrera L;Bassler D;Schwarzer G;Scherer RW;Antes G;von Elm E;Meerpohl JJ;OPEN consortium
通讯作者：
OPEN consortium
影响因子：
2.9
作者：
Miller JE;Korn D;Ross JS
通讯作者：
Ross JS