Why Language Matters in Digital Endpoint Development: Harmonized Terminology as a Key Prerequisite for Evidence Generation.

ABSTRACT:

Background

Developments in the field of digital measures and digitally derived endpoints demand greater attention on globally aligned approaches to enhance digital measure acceptance by regulatory authorities and health technology assessment (HTA) bodies for decision-making. In order to maximize the value of digital measures in global drug development programs and to ensure study teams and regulators are referring to the same items, greater alignment of concepts, definitions, and terminology is required. This is a fast-moving complex field; every day brings new technologies, algorithms, and possibilities. A common language is particularly important when working in multifunctional teams to ensure that there is a clear understanding of what is meant and understood.

Summary

In

SUBMITTER: Leyens L 

PROVIDER: S-EPMC10783888 | biostudies-literature | 2024 Jan-Dec

REPOSITORIES: biostudies-literature