去中心化临床试验(DCT)的创新与探索:华西实践  

Innovation and Exploration of Decentralized Clinical Trial(DCT):A Clinical Practice at West China Hospital

作　　者：刘懿贤 游佳[1] 邸相杰 门宇春[1] 李晓玉[1] 郑莉[1] LIU Yixian;YOU Jia;DI Xiangjie;MEN Yuchun;LI Xiaoyu;ZHENG Li(Clinical Trial Center,West China Hospital,Sichuan University,NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug,Sichuan Chengdu 610041,China)

机构地区：[1]四川大学华西医院临床试验中心,国家药品监督管理局创新药物临床研究与评价重点实验室,四川成都610041

出　　处：《中国医药导刊》2024年第8期774-779,共6页Chinese Journal of Medicinal Guide

基　　金：四川大学华西医院学科卓越发展1·3·5工程临床研究基金(2023HXFH027)。

摘　　要：去中心化临床试验(decentralized clinical trial,DCT)是指在传统临床试验中心以外地点通过远程医疗和移动/本地医疗来执行部分或全部试验相关活动的临床试验。作为一种创新的临床研究方法,DCT落实“以患者为中心”的药物研发理念,可以通过电子化的方式进行远程医疗、远程监测和数据收集,有望突破地域限制,实现临床试验的灵活性和高效性;还能个性化设计治疗方案以满足患者需求,增加患者参与试验的便利性和依从性。DCT正在成为一种重要策略以解决传统临床试验中的挑战,也将成为提升罕见病药物研发质量和效率的关键措施。本研究以四川大学华西医院开展的“米托坦在中国肾上腺皮质癌患者中的全生命周期血药浓度监测及群体分析临床研究”为例,梳理华西医院临床试验中心采用远程招募、电子知情同意、远程采血、远程随访等技术进行罕见病去中心化临床研究的探索与实践,分享华西医院在DCT应用方面的创新举措及经验,探讨如何借助DCT创新模式,加速临床研究新技术、新方法的探索与应用,旨在为更多DCT的应用提供经验和参考,为患者提供更有效和个性化的医疗解决方案。Decentralized clinical trial(DCT)is the clinical trial in which some or all of the trial related activities are conducted through remote and mobile/local healthcare outside of traditional clinical trial centers.As an innovative clinical research method,DCT implements the"patient-centered"drug development concept,which enables remote medical care,remote monitoring,and data collec‐tion through electronic means.DCT can achieve flexibility and efficiency in clinical trials which is expected to break through geographical limitations.Personalized treatment plans can also be designed to meet the needs of patients,increasing their convenience and compliance in participating in trials.DCT is becoming an important strategy to address challenges in traditional clinical trials and will also be a key measure to improve the quality and efficiency of rare disease drug development.This study takes the"Clinical Study on Whole Life Cycle Blood Concentration Monitoring and Population Analysis of Mitotane in Chinese Adrenal Cortical Carcinoma Patients"conducted by West China Hospital of Sichuan University as an example to summarize the exploration and practice of decentralized clinical research on rare diseases using remote recruitment,electronic informed consent,remote blood collection,remote follow-up and other technologies in the Clinical Trial Center of West China Hospital,share the innovative measures and experience of West China Hospital in the application of DCT,explore how to use the DCT innovation model to accelerate the exploration and application of new technologies and methods in clini‐cal research,to provide experience and reference for more DCT applications,and provide more effective and personalized medical solu‐tions for patients.

关 键 词：去中心化临床试验 罕见病 临床实践 肾上腺皮质癌 

分 类 号：R95[医药卫生—药学]