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

IF 12.4 1区医学 Q1 HEALTH CARE SCIENCES & SERVICES

NPJ Digital Medicine Pub Date : 2025-03-06 DOI:10.1038/s41746-025-01513-5

Gül Erdemli, Tina Murphy, Sarah Walinsky

引用次数: 0

Abstract

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.

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来源期刊

NPJ Digital Medicine Multiple-

CiteScore

25.10

自引率

3.30%

发文量

170

审稿时长

15 weeks

期刊介绍： npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics. The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.