Biomarkers Consortium - Workshop: Remote Digital Monitoring for Medical Product Development

FNIH Biomarkers Consortium Digital Monitoring Workshop

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium hosted a public meeting entitled Remote Digital Monitoring for Medical Product Development Workshop on February 18th and 19th, 2020.

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 provided a venue to address challenges and opportunities in the use of remote sensing technologies for improving the probability of success of therapeutic clinical trials. Important characteristics of tool development in this growing digital landscape were addressed in a series of case studies, presentations and open panel sessions and are available at the links below.

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. The participants elaborated a set of steps (framework) that can guide the process of remote monitoring measure development for confident decision making and will also seek to propose a prioritized list of high-impact endpoints or measures that could be addressed through mobile sensing.

Presentations from the Workshop:

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

 

 

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Draft Guidance Document - Biomarker Qualification: Evidentiary Framework
Draft Guidance Document - Qualification Process for Drug Development Tools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

CTTI Recommendations: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

BEST Resource Taxonomy

FNIH Contacts

Steve Hoffmann, Director, Inflammation and Immunity, shoffmann@fnih.org
Joseph Menetski, Associate Vice President, Research Partnerships, jmenetski@fnih.org