英国主要非商业赞助商减少研究浪费的努力:一项混合方法研究

IF 9 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Till Bruckner, Aminul Schuster, Belén Chavarría, Carolina Cruz, Fabiola Karely Lizárraga Illán, Ronak Borana, Tungamirai Ishe Bvute, Daniel Sánchez
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引用次数: 0

摘要

在全球范围内,有相当一部分临床试验因其结果从未公开而最终成为代价高昂的研究浪费。1-3 由此造成的医学证据基础空白伤害了患者,损害了公众健康。4 《赫尔辛基宣言》和世界卫生组织都呼吁公开所有临床试验结果。6 在 2018 年英国议会调查之后,英国的非商业临床试验申办者通过将许多 CTIMP 的摘要结果上传到专门列出药物试验的欧盟临床试验注册中心(EUCTR),大大改善了药物试验(研究性药品临床试验,CTIMP)的结果报告。然而,这些工作通常并没有扩展到其他类型的试验,因为这些试验已被列入其他试验登记册。本研究评估了145项非CTIMP临床试验的发表现状,这些临床试验由英国10家主要非商业赞助商赞助,于2017年完成或终止,有5年的跟踪发表期。首席研究员(TB)于2022年10月27日访问了欧盟试验追踪系统(EU Trials Tracker),确定了英国临床试验中最多产的10家非商业赞助商,并采用...
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Major UK non-commercial sponsors’ efforts to reduce research waste: a mixed-methods study
Worldwide, a significant proportion of clinical trials end up as costly research waste because their results are never made public.1–3 The resulting gaps in the medical evidence base harm patients and undermine public health.4 The Declaration of Helsinki and the WHO both call for all clinical trial results to be made public.5 6 In the wake of a 2018 UK parliamentary enquiry, non-commercial clinical trial sponsors in the UK substantially improved outcome reporting for drug trials (Clinical Trials of Investigative Medicinal Products, CTIMPs) by uploading the summary results of many CTIMPs onto the European Union Clinical Trials Register (EUCTR) which exclusively lists drug trials. However, these efforts typically did not extend to other types of trials, which are listed on other trial registries. This study assesses the current publication status of 145 clinical trials that are not CTIMPs that were sponsored by ten major UK non-commercial sponsors and were completed or terminated in 2017, allowing a 5-year follow-up period for publication. The lead researcher (TB) identified the 10 most prolific non-commercial sponsors of clinical trials in the UK by accessing the EU Trials Tracker on 27 October 2022, employing the …
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来源期刊
BMJ Evidence-Based Medicine
BMJ Evidence-Based Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
8.90
自引率
3.40%
发文量
48
期刊介绍: BMJ Evidence-Based Medicine (BMJ EBM) publishes original evidence-based research, insights and opinions on what matters for health care. We focus on the tools, methods, and concepts that are basic and central to practising evidence-based medicine and deliver relevant, trustworthy and impactful evidence. BMJ EBM is a Plan S compliant Transformative Journal and adheres to the highest possible industry standards for editorial policies and publication ethics.
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