The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium is hosting a public meeting entitled Remote Digital Monitoring for Medical Product Development Workshop on February 18th and 19th, 2020.
Workshop Goals:
- Bring together diverse stakeholders in the field to reach consensus on the use of a single vocabulary that will be understood consistently in the regulatory context
- Present and examine real case studies of remote monitoring in trials to highlight concepts where new vocabulary may be needed
- Identify areas of high medical need that could be addressed using digital system technologies
- Stakeholder alignment and application of an evidence-based framework for the use of digital health technologies for therapeutic research and development
The use of digital health technologies has gained interest from consumers, providers, and researchers as a new way to improve therapeutic research and development (R&D). This workshop will provide a venue to address challenges and opportunities in the use of remote sensing technologies for improving the probability of success of therapeutic clinical trials. The agenda will highlight important characteristics of tool development in this growing digital landscape by using a series of real life case studies that can be described and discussed.
The planning team will incorporate the insights and proceedings of the Workshop into a white paper and related manuscript that can be used to develop operational and regulatory guidance. This meeting will suggest a set of steps (framework) that can guide the process of remote monitoring measure development for confident decision making. The team will also seek to propose a prioritized list of high-impact endpoints or measures that could be addressed through mobile sensing. This two-day meeting will provide a forum for open discussion on multiparametric mobile monitoring approaches and a framework for analytical and clinical validation needs for drug developers and regulators.
Reference Materials
Guidance Documents
Draft Guidance Document - Biomarker Qualification: Evidentiary Framework
Draft Guidance Document - Qualification Process for Drug Development Tools
Scientific Publications
What evidence do we need for biomarker qualification? C. Leptak, J. P. Menetski, J. A. Wagner, J. Aubrecht, L. Brady, M. Brumfield, W. W. Chin, S. Hoffmann, G. Kelloff, G. Lavezzari, R. Ranganathan, J.-M. Sauer, F. D. Sistare, T. Zabka, D. Wholley, Sci Transl Med. 2017 Nov 22;9(417). pii: eaal4599. doi: 10.1126/scitranslmed.aal4599.
Traditional and Digital Biomarkers: Two Worlds Apart? L. Babrak, J. Menetski, M. Rebhan, G. Nisato, M. Zinggeler, N. Brasier, K. Baerenfaller, T. Brenzikofer, L. Baltzer, C. Vogler, L. Gschwind, C. Schneider, F. Streiff, P. Groenen, E. Miho, Digit Biomark 2019;3:92–102, DOI: 10.1159/000502000
Digital Medicine: A Primer on Measurement. A. Coravos, J. Goldsack, D.R. Karlin, C. Nebeker, E. Perakslis, N. Zimmerman, M.K. Erb, Digit Biomark 2019;3:31–71,DOI: 10.1159/000500413
Workshop Overview and Pre-Read Resources
FNIH Contacts
Steve Hoffmann, Director, Inflammation and Immunity, shoffmann@fnih.org
Joseph Menetski, Associate Vice President, Research Partnerships, jmenetski@fnih.org