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欧洲临床试验资助者关于临床试验注册和报告的政策是否在改善?一项横断面研究。

Are European clinical trial funders policies on clinical trial registration and reporting improving? A cross-sectional study.

作者信息

O'Riordan Marguerite, Haslberger Martin, Cruz Carolina, Suljic Tarik, Ringsten Martin, Bruckner Till

机构信息

TranspariMED, Bristol, UK.

College of Health and Life Sciences, Aston Medical School, Aston University, Birmingham, UK.

出版信息

J Clin Transl Sci. 2023 Jul 14;7(1):e166. doi: 10.1017/cts.2023.590. eCollection 2023.

Abstract

OBJECTIVES

Assess the extent to which the clinical trial registration and reporting policies of 25 of the world's largest public and philanthropic medical research funders meet best practice benchmarks as stipulated by the 2017 WHO Joint Statement, and document changes in the policies and monitoring systems of 19 European funders over the past year.

DESIGN SETTING PARTICIPANTS

Cross-sectional study, based on assessments of each funder's publicly available documentation plus validation of results by funders. Our cohort includes 25 of the largest medical research funders in Europe, Oceania, South Asia, and Canada.

INTERVENTIONS

Scoring all 25 funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into three primary categories: trial registries, academic publication, and monitoring, plus validation of results by funders.

MAIN OUTCOME MEASURES

How many of the 11 WHO best practice items each of the 25 funders has put into place, and changes in the performance of 19 previously assessed funders over the preceding year.

RESULTS

The 25 funders we assessed had put into place an average of 5/11 (49%) WHO best practices. Only 6/25 funders (24%) took the PI's past reporting record into account during grant application reviews. Funders' performance varied widely from 0/11 to 11/11 WHO best practices adopted. Of the 19 funders for which 2021(2) baseline data was available, 10/19 (53%) had strengthened their policies over the preceding year.

CONCLUSIONS

Most medical research funders need to do more to curb research waste and publication bias by strengthening their clinical trial policies.

摘要

目标

评估全球25家最大的公共和慈善医学研究资助机构的临床试验注册和报告政策在多大程度上符合世界卫生组织2017年联合声明规定的最佳实践基准,并记录19家欧洲资助机构在过去一年中政策和监测系统的变化。

设计、地点、参与者:横断面研究,基于对每个资助机构公开文件的评估以及资助机构对结果的验证。我们的队列包括欧洲、大洋洲、南亚和加拿大的25家最大的医学研究资助机构。

干预措施

使用基于世界卫生组织最佳实践基准的11项评估工具对所有25家资助机构进行评分,分为三个主要类别:试验注册、学术发表和监测,以及资助机构对结果的验证。

主要结局指标

25家资助机构中每家落实了世界卫生组织11项最佳实践中的多少项,以及19家之前评估过的资助机构在前一年的表现变化。

结果

我们评估的25家资助机构平均落实了5/11(49%)的世界卫生组织最佳实践。只有6/25(24%)的资助机构在资助申请评审过程中考虑了主要研究者过去的报告记录。资助机构的表现差异很大,采用的世界卫生组织最佳实践从0/11到11/11不等。在有2021年(2)基线数据的19家资助机构中,10/19(53%)在过去一年中加强了其政策。

结论

大多数医学研究资助机构需要通过加强其临床试验政策来进一步减少研究浪费和发表偏倚。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dbd7/10425870/8b40326931c2/S2059866123005903_fig1.jpg

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