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资助者在监测临床试验注册和报告政策合规性方面面临的挑战:对英国资助和注册数据的分析

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK.

作者信息

Knowles Rachel L, Ha Kam Pou, Mueller Julia, Rawle Frances, Parker Rosa

机构信息

Medical Research Council, London, UK

Medical Research Council, London, UK.

出版信息

BMJ Open. 2020 Feb 17;10(2):e035283. doi: 10.1136/bmjopen-2019-035283.

Abstract

OBJECTIVES

To evaluate compliance by researchers with funder requirements on clinical trial transparency, including identifying key areas for improvement; to assess the completeness, accuracy and suitability for annual compliance monitoring of the data routinely collected by a research funding body.

DESIGN

Descriptive analysis of clinical trials funded between February 2011 and January 2017 against funder policy requirements.

SETTING

Public medical research funding body in the UK.

DATA SOURCES

Relevant clinical trials were identified from grant application details, post-award grant monitoring systems and the International Standard Randomised Controlled Trial Number (ISRCTN) registry.

MAIN OUTCOME MEASURE

The proportion of all Medical Research Council (MRC)-funded clinical trials that were (a) registered in a clinical trial registry and (b) publicly reported summary results within 2 years of completion.

RESULTS

There were 175 grants awarded that included a clinical trial and all trials were registered in a public trials registry. Of 62 trials completed for over 24 months, 42 (68%) had publicly reported the main findings by 24 months after trial completion; 18 of these achieved this within 12 months of completion. 11 (18%) trials took >24 months to report and 9 (15%) completed trials had not yet reported findings. Five datasets were shared with other researchers.

CONCLUSIONS

Compliance with the funder policy requirements on trial registration was excellent. Reporting of the main findings was achieved for most trials within 24 months of completion; however, the number of unreported trials remains a concern and should be a focus for future funder policy initiatives. Identifying trials from grant management and grant monitoring systems was challenging therefore funders should ensure investigators reliably provide trial registries with information and regularly update entries with details of trial publications and protocols.

摘要

目的

评估研究人员对资助者关于临床试验透明度要求的遵守情况,包括确定关键改进领域;评估研究资助机构定期收集的数据在年度合规监测方面的完整性、准确性和适用性。

设计

根据资助者政策要求,对2011年2月至2017年1月期间资助的临床试验进行描述性分析。

背景

英国的公共医学研究资助机构。

数据来源

从资助申请细节、资助后监测系统和国际标准随机对照试验编号(ISRCTN)注册库中识别相关临床试验。

主要观察指标

所有由医学研究理事会(MRC)资助的临床试验中,(a)在临床试验注册库中注册的比例,以及(b)在完成后2年内公开报告总结结果的比例。

结果

共授予175项包含临床试验的资助,所有试验均在公共试验注册库中注册。在62项完成超过24个月的试验中,42项(68%)在试验完成后24个月内公开报告了主要发现;其中18项在完成后12个月内做到了这一点。11项(18%)试验花费超过24个月才报告,9项(15%)完成的试验尚未报告结果。有5个数据集与其他研究人员共享。

结论

在试验注册方面对资助者政策要求的遵守情况极佳。大多数试验在完成后24个月内报告了主要发现;然而,未报告试验的数量仍然令人担忧,应成为未来资助者政策举措的重点。从资助管理和资助监测系统中识别试验具有挑战性,因此资助者应确保研究人员可靠地向试验注册库提供信息,并定期更新试验出版物和方案细节的条目。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a59/7045207/a9f5fb357c76/bmjopen-2019-035283f01.jpg

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