精准医疗临床研究的关键挑战与优化建议  

Key Challenges and Optimization Recommendations of Clinical Research for Personalised Medicine

作　　者：杜静婷 冷烨 祁婉婷 韩洞明 王丽丽 黄慧瑶[1] 王闻雅 李宁[1] DU Jingting;LENG Ye;QI Wanting;HAN Dongming;WANG Lili;HUANG Huiyao;WANG Wenya;LI Ning(National Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences,Beijing 100021,China;Beijing Tsinghua Changgung Hospital,Beijing 102218,China;BGI Research,Guangdong Shenzhen 518083,China;College of Life Sciences,University of Chinese Academy of Sciences,Beijing 100049,China)

机构地区：[1]国家癌症中心,中国医学科学院肿瘤医院,北京100021 [2]清华大学附属北京清华长庚医院,北京102218 [3]深圳华大生命科学研究院,广东深圳518083 [4]中国科学院大学生命科学学院,北京100049

出　　处：《中国医药导刊》2024年第1期44-47,共4页Chinese Journal of Medicinal Guide

基　　金：国家重点研发计划资助项目,科技部重点研发计划“政府间国际科技创新合作”重点专项[项目编号:2021YFE0192400,项目名称:中国-欧盟国际精准医疗领域合作支持计划(IC2PerMed)]。

摘　　要：近年来,随着现代生物技术的成熟,在国际社会共同推动下,致力于为患者提供个性化医疗服务的精准医疗及其相关临床研究取得了显著进展。为促进精准医疗研究及其发展环境的优化,欧盟委员会设立了国际精准医疗联盟(ICPerMed),以专项研究的形式支持精准医疗健康发展。ICPerMed于2020年启动PERMIT专项,该专项致力于推动精准医疗临床研究的发展。本研究围绕PERMIT专项的概况、研究目标、工作内容及其针对精准医疗临床研究发展的相关工作建议等几个方面进行系统介绍;同时结合我国精准医疗临床研究的进展与挑战,提出促进精准医疗临床研究健康高效发展的若干关键工作方向,包括政策制定、监管框架和资金投入等,以供相关工作参考。In recent years,with the maturity of modern biological technology and the joint promotion of the international community,personalised medicine and its clinical research,which is dedicated to providing personalized medical services to patients,have made sig-nificant progress.In order to promote personalised medicine research and optimize its ecological environment,the European Commission established the International Consortium of Personalised Medicine(ICPerMed)to support the healthy development of personalised medi-cine in the form of project research.ICPerMed set the PERMIT project in 2020,which is dedicated to promoting the development of clini-cal research for personalised medicine.This study systematically introduces the overview,research goals,work content of PERMIT,and its related work suggestions for the development of clinical research for personalised medicine.At the same time,combined with the prog-ress and challenges of clinical research for personalised medicine in China,this study proposes several key work directions to promote healthy and efficient development of clinical research for personalised medicine,including policy formulation,regulatory framework and financial investment,so as to provide reference for related work.

关 键 词：精准医疗 临床研究 ICPerMed PERMIT项目 肿瘤精准治疗 

分 类 号：R197[医药卫生—卫生事业管理] R95[医药卫生—公共卫生与预防医学]