数字健康技术衍生临床试验终点的资格和接受的监管途径:赞助商的考虑

Jessie P Bakker1, Elena S Izmailova1, Aude Clement2

  • 1Koneksa Health, New York, New York, USA.

概括

基于传感器的数字健康技术 (sDHT) 为药物开发提供远程数据捕获,但存在监管障碍. 本综述比较了研究新药 (IND) 和药物开发工具 (DDT) 的途径,以帮助SDHT的采用.

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