Drug Clinical Trial Development Driven by Digital Health Technologies
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.
digital health technologydigital biomarkersdigital clinical trial endpointsclinical trial developmentregulatory science
国家科技期刊平台
NSTL
万方数据
