Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development

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. I...

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Bibliographic Details
Main Authors: Gül Erdemli, Tina Murphy, Sarah Walinsky
Format: Article
Language:English
Published: Nature Portfolio 2025-03-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01513-5
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