ICH E17多地区临床试验指导原则的临床视角解读

Introduction of ICH E17 General Principle on Planning and Designing Multi-Regional Clinical Trials from clinical consideration

随着我国新药研发和临床研究水平的不断提高,国内众多医疗机构越来越多地参加多地区/多中心临床试验。为了促进全球化药物同步研发,提高全球注册效率,2017年11月,ICH E17专家工作组通过人用药品注册技术要求国际协调会议(International Council for Harmonization,ICH)再次修订了"多地区临床试验计划与设计的总体原则",期望在2018年推进此指导原则的实施。本文将从临床角度介绍E17指导原则中的主要内容,并简述多地区/多中心临床试验在国内的发展概况。

As the continuous improvement of the new drug and clinical research in China,more and more domestic medical institutions participated in the multi-regional clinical trials（ MRCT）. With the increasing globalisation of medicines development,as well as making it easier to seek approval of global trials,the E17,General principle on planning and designing MRCT,was adopted by Expert Working Group and the regulatory members of the ICH（ International Council for Harmonization） Assembly under step 4 in November 2017. ICH E17 Expert Working Group will promote the implementation of this Guideline in 2018. This paper will introduce a major Guideline from clinical consideration,and briefly review the development of MRCT in China.