National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.
National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA
BMJ. 2022 Jun 10;377:e067745. doi: 10.1136/bmj-2021-067745.
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.
Qualitative analysis.
ClinicalTrials.gov trial registry.
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.
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).
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.
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。
定性分析。
ClinicalTrials.gov 试验注册库。
概述了试验报告系统的既定目标和相关实践，回顾了 MPRP 的示例和关键特征，并确定了在向依赖于一个协议对应一个研究的传统临床试验设计模型的数据库注册和报告汇总结果方面的具体挑战。
提出了一种报告方法，适应 MPRP 及其结果的复杂研究设计。该方法涉及在一个 MPRP 协议内为每个子研究使用单独的注册记录（注意潜在的例外情况）。
描述并说明了所提出的方法如何允许对每个子研究的预定设计进行清晰、描述性、结构化的信息，并支持在每个子研究完成后及时报告结果。尽管重点是向 ClinicalTrials.gov 报告，但该方法支持在试验注册库和结果数据库中更广泛的应用。本文旨在激发利益相关者对该方法的进一步讨论，提高对 MPRP 报告改进的认识，并鼓励在全球范围内的试验注册库之间实现协调。
