Ontology highlight
ABSTRACT:
SUBMITTER: Crouthamel M
PROVIDER: S-EPMC8460981 | biostudies-literature | 2021 Sep-Dec
REPOSITORIES: biostudies-literature
Crouthamel Michelle M Mather Robert J RJ Ramachandran Suraj S Bode Kai K Chatterjee Godhuli G Garcia-Gancedo Luis L Kim Joseph J Alaj Rinol R Wipperman Matthew F MF Leyens Lada L Sillen Henrik H Murphy Tina T Benecky Michael M Maggio Brandon B Switzer Thomas T
Digital biomarkers 20210902 3
The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal ...[more]