JAMA：如何使用和解释平台试验的结果：医学文献用户指南

分享智慧共同成长

Abstract

Platform trials are a type of randomized clinical trial that allow simultaneous comparison of multiple intervention groups against a single control group that serves as a common control based on a prespecified interim analysis plan. The platform trial design enables introduction of new interventions after the trial is initiated to evaluate multiple interventions in an ongoing manner using a single overarching protocol called a master (or core) protocol. When multiple treatment candidates are available, rapid scientific therapeutic discoveries may be made. Platform trials have important potential advantages in creating an efficient trial infrastructure that can help address critical clinical questions as the evidence evolves. Platform trials have recently been used in investigations of evolving therapies for patients with COVID-19. The purpose of this Users’ Guide to the Medical Literature is to describe fundamental concepts of platform trials and master protocols and review issues in the conduct and interpretation of these studies. This Users’ Guide is intended to help clinicians and readers understand articles reporting on interventions evaluated using platform trial designs.

摘要翻译（仅供参考）

平台试验是一种随机临床试验，允许多个干预组与单一对照组同时进行比较，该对照组根据预先指定的中期分析计划作为共同对照。平台试验设计能够在试验开始后引入新的干预措施，使用一个被称为主（或核心）方案的单一总体方案，以持续的方式评估多种干预措施。当有多种候选治疗方法时，可以快速地进行科学治疗发现。平台试验在创建高效的试验基础设施方面具有重要的潜在优势，可以随着证据的发展而帮助解决关键的临床问题。最近，平台试验已被用于对COVID-19患者不断发展的疗法进行调查。本医学文献用户指南的目的是描述平台试验的基本概念，以及进行和解释这些研究的主要协议和审查问题。本《用户指南》旨在帮助临床医生和读者理解报告使用平台试验设计评估的干预措施的文章。

原文链接：

https://jamanetwork.com/journals/jama/article-abstract/2787723

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