小柯机器人

美国国立卫生研究院Tony Tse团队研究了在ClinicalTrials.gov上报告主方案研究设计的方法。2022年6月10日出版的《英国医学杂志》发表了这项成果。

为了描述一种与现有良好报告实践一致的报告主方案研究计划（MPRP）的方法，并使用结构化信息传达总体主方案和每个子研究的设计，研究组针对在ClinicalTrials.gov上注册的试验进行了一项定性分析。主要观察指标为概述试验报告系统的既定目标和相关实践，回顾MPRPs的示例和关键特性，并确定在传统临床试验设计数据库中注册和报告总结结果的具体挑战，这些试验设计依赖于每个方案一项研究的模型。

研究组提出了一种报告方法，以适应MPRP的复杂研究设计及其结果。这种方法涉及在一个MPRP方案中为每个子研究使用单独的注册记录（注意到潜在的例外情况）。研究组描述和说明了所提出的方法如何为每个子研究的预先指定设计提供清晰、描述性和结构化的信息，并支持在每个子研究完成后及时报告结果。

虽然重点是向ClinicalTrials.gov报告，但该方法支持在试验登记处和结果数据库中更广泛的应用。该研究旨在鼓励利益相关者进一步讨论这一方法，提高对改进MPRP报告必要性的认识，并鼓励全球试验登记处之间的协调。

附：英文原文

Title: Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis

Author: Rebecca J Williams, Heather D Dobbins, Tony Tse, Sandy D Chon, David Loose, Gisele A Sarosy, Sheila A Prindiville, Frank W Rockhold, Deborah A Zarin

Issue&Volume: 2022/06/10

Abstract:

Objective To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.

Design Qualitative analysis.

Data sources ClinicalTrials.gov trial registry.

Main outcome measures Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified.

Results A reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted).

Conclusions How the proposed approach allows for clear, descriptive, structured information about each substudy’s prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally.

DOI: 10.1136/bmj-2021-067745

Source: https://www.bmj.com/content/377/bmj-2021-067745

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
官方网址：http://www.bmj.com/
投稿链接：https://mc.manuscriptcentral.com/bmj