Erdemli Gül, Murphy Tina, Walinsky Sarah
Novartis Pharmaceuticals Corporation, Cambridge, MA, USA.
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
NPJ Digit Med. 2025 Mar 6;8(1):142. doi: 10.1038/s41746-025-01513-5.
Regulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development program including health authority consultations to ensure alignment with regulatory requirements. In this manuscript, the authors provide stepwise guidance for successful implementation of DHT-derived endpoints in clinical trials for drug development.
监管机构对数字健康技术（DHT）衍生终点的认可可能是一个漫长、多方面且成本高昂的过程。成功依赖于制定一项全球战略，作为开发计划的一部分，包括与卫生当局进行磋商，以确保符合监管要求。在本手稿中，作者为在药物开发临床试验中成功实施DHT衍生终点提供了逐步指导。
