美国食品药品监督管理局以患者为中心的药物开发系列指导原则1-《综合和有代表性的信息收集指导原则》介绍

Introduction of U. S. Food and Drug Administration patient-focused drug development guidance 1-Collecting comprehensive and representative input

以患者为中心的药物开发是将患者的经验、观点、需求和优先考虑等纳入药物开发和评估的一种系统性方法。美国食品药品监督管理局成立了以患者为中心的药物开发小组,致力于以患者为中心的系列指导原则的制定。目前计划中有4项指导原则,其中指导原则1《综合和有代表性的信息收集指导原则》已正式发布。本文对指导原则1相关内容进行介绍并思考对我国中药疗效评价的借鉴作用。

Patient-focused drug development is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The Patient-Focused Drug Development Program Staff of U.S. Food and Drug Administration is developing a series of four methodological patient-focused drug development guidance documents. The guidance 1-collecting comprehensive and representative input have been finalized. This paper introduce the contents of guidance 1 and considers its reference for the effect evaluation of Traditional Chinese Medicine.