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
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.
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引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据