中国食品药品监管Issue(7)：36-45,10.DOI:10.3969/j.issn.1673-5390.2024.07.004
数字健康技术驱动下的药物临床试验研发
Drug Clinical Trial Development Driven by Digital Health Technologies
张新宇 1张磊 2程龙1
作者信息
- 1. 荣昌生物制药(烟台)股份有限公司
- 2. 上海中医健康服务协同创新中心
- 折叠
摘要
Abstract
As the pharmaceutical industry faces declining research and development productivity,the limitations of traditional clinical endpoints in reflecting changes in disease status are becoming increasingly apparent.Digital health technologies,by providing continuous and objective health data,can improve clinical trial design,enhance the personalization of treatment plans,and increase patient satisfaction.This article showcases the application of digital clinical endpoints in drug development through cases such as the stride velocity 95th centile in Duchenne muscular dystrophy,smartphone applications for multiple sclerosis,nocturnal scratching and sleep monitoring for atopic dermatitis patients,and the measurement of physical activity in cancer cachexia.It analyzes the current state of development of digital clinical endpoints in China and exploratively proposes suggestions for strengthening regulatory science research and establishing a certification process for digital clinical endpoints,in order to provide references for promoting the development of drug clinical trials driven by digital health technologies in China.关键词
数字健康技术/数字生物标志物/数字临床试验终点/临床试验研发/监管科学Key words
digital health technology/digital biomarkers/digital clinical trial endpoints/clinical trial development/regulatory science分类
医药卫生引用本文复制引用
张新宇,张磊,程龙..数字健康技术驱动下的药物临床试验研发[J].中国食品药品监管,2024,(7):36-45,10.
