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:
- Challenges for the Implementation of Digital Monitoring Technologies in Drug Development - Jennifer Goldsack (DiME) | Watch the video
- Regulatory Guidance and Evidentiary Criteria for Drug Development Tools - Chris Leptak (FDA/CDER) | Watch the video
- Review of the General Framework and Case Study Set Up: Issues and Considerations - Joseph Menetski (FNIH) and John Wagner (Foresite Capital) | Watch the video
- Regulatory Guidance and Evidentiary Principles for Digital Health Technology Development - Bakul Patel (FDA/CDRH) | Watch the video
- NIH Pipeline in Digital Technologies - Jill Heemskerk (NIH/NIBIB) | Watch the video
- Case Study 1: Mobile Parkinson Observatory for Worldwide, Evidence-based Reserch (mPower) and Parkinson's Disease - Diane Stephenson (Critial Path Institute), Dan Karlin (HealthMode), Ahi Pratap (SageBionetworks), Ninad Amondikar (MJFF), Xeumei Cai (Pfizer) | Watch the video
- Case Study 2: Cardiac Monitoring in Phase 1 Clinical Trials - Elena Izmaliova (Koneska Health), John Wagner (Foresite Capital), Vadim Zipunnikov (Johns Hopkins University) | Watch the video
- Case Study 3: Continous Glucose Monitoring & Remote Digital Monitoring (VERKKO Study) - Roberto Calle (Pfizer), Nadir Ammour (Sanofi) | Watch the video
- Case Study 4: Strive Velocity 95th Centile 2° Endpoint in Duchenne's Muscular Dystrophy - Pat Furlong (PPMD), Laurent Servais (University of Oxford), Francesca Cerreta (EMA) | Watch video
- Case Study 5: Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR-MDD) - Matthew Hotopf (King's College), Vaibhav Narayan, Linda Brady (NIH/NIMH) | Watch video
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
FNIH Contacts
Steve Hoffmann, Director, Inflammation and Immunity, shoffmann@fnih.org
Joseph Menetski, Associate Vice President, Research Partnerships, jmenetski@fnih.org