摘要
随着制药行业研发能力的下降,传统的临床试验终点在反映疾病状态变化方面的局限性日益凸显。数字健康技术通过提供连续、客观的健康数据,能够改善临床试验设计,提高治疗方案的个性化,并提升患者满意度。本文通过介绍杜氏肌营养不良症的步幅速度第95百分位数和多发性硬化症的智能手机应用程序、特应性皮炎患者的夜间抓痒和睡眠监测以及癌性恶病质患者身体活动的测量等案例,展示了数字临床试验终点在药物开发中的应用,分析了我国数字临床试验终点的发展现状,并探索性地提出了加强监管科学研究和建立数字临床试验终点认证程序的建议,以期为促进我国数字健康技术驱动下的药物临床试验的发展提供借鉴。
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.
作者
张新宇
张磊
程龙
ZHANG Xin-yu;ZHANG Lei;CHENG Long(Remegen Co.,Ltd.;Shanghai Innovation Center of TCM health Service)
出处
《中国食品药品监管》
2024年第7期36-45,共10页
China Food & Drug Administration Magazine
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
digital health technology
digital biomarkers
digital clinical trial endpoints
clinical trial development
regulatory science
