以患者为中心药物研发相关概念介绍  

Introduction of patient-focused drug development related concepts

作　　者：吴晓蕾 史梦龙 张晨瑶 马毓聪 杜亮[2] 刘炳林[3] 曹璐佳 张俊华 WU Xiaolei;SHI Menglong;ZHANG Chenyao;MA Yucong;DU Liang;LIU Binglin;CAO Lujia;ZHANG Junhua(Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital of Sichuan University,Chengdu 610041,P.R.China;Center for Drug Evaluation,China Food and Drug Administration,Beijing 10002,P.R.China)

机构地区：[1]天津中医药大学循证医学中心,天津301617 [2]四川大学华西医院中国循证医学中心,成都610041 [3]国家食品药品监督管理局药品审评中心,北京100022

出　　处：《中国循证医学杂志》2023年第12期1472-1477,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家中医药管理局青年岐黄学者支持项目(国中医药人教函[2020]218号)(编号:YL2202020414);组分中药国家重点实验室青苗基金(编号:YL230102013723)。

摘　　要：患者作为疾病亲身经历者,对疾病的痛苦感受和对健康产品的需求最直接也最明确。虽然当前防治疾病和维护健康的技术手段不断丰富,但人类的疾病负担并未减少,患者的健康需求并未充分满足。因此,“以患者为中心药物研发”势在必行。通过多渠道全面收集患者的诉求,并将收集的信息纳入药物研发全过程,有助于确保患者的体验、观点、需求和优先事项被关注重视。本文将从相关概念、发展过程、面临的具体问题等方面对“以患者为中心药物研发”进行介绍。The patient,as the person who experiences the disease first-hand,has the most direct and accurate experience of the pain of the disease and the most accurate need for health products.Although there is a vast array of technological means to combat disease and maintain health,the human burden of disease has not been reduced and the health needs of patients have not been fully met.Therefore,"patient-focused drug development"is imperative.Gathering comprehensive information from patients through multiple channels and incorporating this information into the entire drug development process can help ensure that patients'experiences,perspectives,needs and priorities are taken into account and valued.This article will introduce the concept,development process and the specific problems it faces in patient-focused drug development.

关 键 词：以患者为中心药物研发 临床结局评估 患者体验数据 

分 类 号：R95[医药卫生—药学]