主协议平台试验设计及其在相关领域的应用

Q4 Medicine 中国循证医学杂志 Pub Date : 2021-01-01 DOI:10.7507/1672-2531.202104005

Z. Guan, Y. Liu, J. Zhang, Yaolong Chen, H. Dai, X. Zhang, M. Hu, H. Shang

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引用次数: 0

摘要

主方案平台试验是在单一疾病背景下，对多种治疗或不同治疗组合进行一致评估的试验，可能在不同疾病亚型的几个子研究中，允许多种治疗根据一定的决策算法进入或退出试验平台。与传统的临床试验设计相比，主方案平台试验作为一种科学的临床试验创新模式，可以加速药物的评价，解决众多药物等待评价与疾病缺乏有效治疗之间的矛盾。本文以2020年英国牛津大学牵头开展的新冠肺炎住院患者(恢复期)大规模随机对照临床试验为例，介绍主方案平台试验的概念、设计原则和基本试验流程，为药物临床研究提供方法学参考。©2021华西医科大学。版权所有。

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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Design of the master protocol platform trial and its application in related fields

The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs. © 2021 West China University of Medical Science. All rights reserved.

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来源期刊

中国循证医学杂志 Medicine-Medicine (all)

CiteScore

0.50

自引率

0.00%

发文量

4677

期刊介绍： The Chinese Journal of Evidence-Based Medicine is the official Chinese language journal of the Cochrane China. The journal aims to present the newest research results and promote the international understanding and development of evidence-based medicine, including decision-making, research, practice, and education. Papers in any of the following fields will be considered: editorial, commentary, systematic review, clinical trial and register, methodology, policy-making and management, drug safety, education, patient safety, and knowledge translation. The journal encourages submissions from interdisciplinary studies and all manuscripts are blind peer reviewed.