Topic

ecoa

Electronic clinical outcome assessment systems and operations.

Digital Health Technologies as Trial Endpoints: Fit-for-Purpose Evidence

An evidence-based guide to validating digital health technologies (DHTs) for clinical trial endpoints under FDA's December 2023 guidance, covering verification, validation, and missing data.

Aug 279 minBy Ran Chen

Editorial still life of an unbranded sensor wristband with an inactive screen beside a closed unmarked protocol folio on parchment