美国食品药品监督管理局（FDA）于2024年9月发布了《将药物和生物制品的随机对照试验整合进常规临床诊疗实践》的指导原则草案，该指导原则草案提出了将研究整合到常规临床实践中的随机对照试验（RCT）的原理和方法，说明了在该种试验中各方的角色，并提出了“质量源于设计（QbD）”的关键试验设计理念。介绍该指导原则草案主要内容及相关案例——RECOVERY试验，并分析我国开展此类试验面临的挑战与应对策略，以期为相关机构提供参考。

The U.S. Food and Drug Administration (FDA) released a draft guidance titled Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in September 2024. This draft guidance outlines the principles and methodologies for integrating Randomized Controlled Trials (RCTs) into routine clinical practice. It clarifies the roles of various stakeholders involved in such trials and introduces the critical design concept of “Quality by Design” (QbD). This article aims to introduce the main contents of this draft guidance and the related case (the RECOVERY trial), and discuss the challenges and corresponding strategies for conducting such trials in China, in order to provide insights for relevant institutions.

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