Reporting summary results in clinical trial registries: updated guidance from WHO.

IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
An-Wen Chan, Ghassan Karam, Justin Pymento, Lisa M Askie, Luiza R da Silva, Ségolène Aymé, Christopher Marc Taylor, Lotty Hooft, Anna Laura Ross, Vasee Moorthy
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引用次数: 0

Abstract

The importance of publicly registering clinical trials and reporting their results in registries is widely recognised. While substantial progress has been made with registering trials before enrolment, the availability of results in registries remains uncommon despite expanding legislative and funder requirements-leading to an incomplete evidence base and avoidable waste of resources, particularly for unpublished trials. This paper discusses the rationale for reporting summary results in trial registries, reviews the current landscape of registry policies, and presents new WHO guidance for reporting results in registries. The 2025 WHO guidance was developed after consultation with relevant parties, including researchers, patients, sponsors, funders, regulators, journal editors, registry administrators, and the public. The guidance defines eight minimum items that are essential for understanding and interpreting the summary results for all trials. Implementation of the WHO guidance by trial registries, broad adherence by investigators and sponsors, and endorsement by funders, regulators, legislators, research ethics committees, patient organisations, and journals can help enhance the contribution of trials to scientific knowledge, patient care, and health policy.

报告临床试验注册的摘要结果:世卫组织的最新指南。
公开注册临床试验并在注册中心报告其结果的重要性已得到广泛认可。虽然在注册前对试验进行登记方面取得了重大进展,但尽管立法和供资要求不断扩大,但在登记处获得结果的情况仍然很少,这导致证据基础不完整和可避免的资源浪费,特别是对未发表的试验而言。本文讨论了在试验注册中心报告摘要结果的基本原理,回顾了注册中心政策的当前情况,并提出了世卫组织在注册中心报告结果方面的新指南。世卫组织2025年指南是在与研究人员、患者、赞助者、资助者、监管机构、期刊编辑、注册管理人员和公众等相关各方协商后制定的。该指南定义了对理解和解释所有试验的总结结果至关重要的8个最小项目。试验登记处实施世卫组织指南,研究者和赞助者广泛遵守,以及资助者、监管机构、立法者、研究伦理委员会、患者组织和期刊的认可,有助于加强试验对科学知识、患者护理和卫生政策的贡献。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lancet Global Health
Lancet Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
44.10
自引率
1.20%
发文量
763
审稿时长
10 weeks
期刊介绍: The Lancet Global Health is an online publication that releases monthly open access (subscription-free) issues.Each issue includes original research, commentary, and correspondence.In addition to this, the publication also provides regular blog posts. The main focus of The Lancet Global Health is on disadvantaged populations, which can include both entire economic regions and marginalized groups within prosperous nations.The publication prefers to cover topics related to reproductive, maternal, neonatal, child, and adolescent health; infectious diseases (including neglected tropical diseases); non-communicable diseases; mental health; the global health workforce; health systems; surgery; and health policy.
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