Putting Theory into Practice by Developing a Novel Digital Health Technology-Derived Endpoint in Sleep Quality
We outline how various stakeholders collaborated to leverage prior evidence, interacted with regulatory authority, and incorporated a novel DHT-derived endpoint into clinical development programs. Evidence and data generated in the present project have the potential to build the basis for further endpoint and DHT development and validation.
Authors
- Karen Sullivan (ORCID: https://orcid.org/0000-0002-5486-0247)
- John H. Batchelor (ORCID: https://orcid.org/0000-0003-3154-1654)
- Amy Bertha
- Frank Kramer
- Joachim K. Krauss (ORCID: https://orcid.org/0000-0002-0675-9064)
- Jaya Pal (ORCID: https://orcid.org/0000-0001-7843-283X)
- Parla Yuksel
- Marta Stepien
Institutions
- Bayer (United States) (US)
- Finnish National Agency for Education (FI)
- Bayer (Germany) (DE)
Publication Details
- Journal
- Digital Biomarkers
- Published
- 2025-12-18
- DOI
- https://doi.org/10.1159/000549984
- Primary Topic
- ICT in Developing Communities
- Type
- article
- Field-Weighted Citation Impact
- 0.00