Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract.

ABSTRACT:

Background

Clinical trials often use digital technologies to collect data continuously outside the clinic and use the derived digital endpoints as trial endpoints. Digital endpoints are also being developed to support diagnosis, monitoring, or therapeutic interventions in clinical care. However, clinical validation stands as a significant challenge, as there are no specific guidelines orienting the validation of digital endpoints.

Objective

This paper presents the protocol for a scoping review that aims to map the existing methods for the clinical validation of digital endpoints.

Methods

The scoping review will comprise searches from the electronic literature databases MEDLINE (PubMed), Scopus (including conference proceedings), Embase, IEEE (Institute of Electrical a

SUBMITTER: Rego S 

PROVIDER: S-EPMC10636620 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature