Remote digital monitoring technologies can be used in clinical trials to evaluate novel endpoints that provide information that was previously difficult or impossible to obtain. These technologies could also make trials more efficient and less burdensome to participants while providing a more meaningful and complete understanding of patients’ conditions and responses. However, despite these potential benefits, of the >73,000 active clinical trials listed on ClinicalTrials.gov, only
55 digital efficacy endpoints are currently being used in industry-sponsored trials of new medical products. Here, we highlight key points from a February 2020 workshop on remote digital monitoring convened by the Foundation for the National Institutes of Health Biomarkers Consortium, which involved experts from regulatory agencies, government, pharma and biotech companies, technology developers, patient groups and a variety of consortia (see
Related links for slides and recordings). We focus on points that could be immediately useful during the COVID-19 pandemic in situations where clinic visits are restricted by quarantine measures and travel restrictions and the eligibility and ability of patients to participate in trials is affected.
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Acknowledgements
The authors thank the speakers, panelists and other participants for their contributions to the workshop including planning committee members: Steve Berman (FDA/CDER), Linda S. Brady (NIH/NIMH), Roberto Calle (Pfizer), Luca Foschini (Evidation), Rob Goldel (FDA/CDRH), Jill Heemskerk (NIH/NIBIB), Peter Honig (Pfizer), Tania Kamphaus (FNIH), Eeshan Khandekar (National Academy of Sciences, Engineering, and Medicine), Husseini Manji (Janssen), Bray Patrick-Lake (Evidation), Jagdeep Podichetty (Critical Path Institute), Ed Ramos (NIH/OD), Matt Raymond (PhRMA), Carolyn Shore (National Academy of Sciences, Engineering, and Medicine), Bruce Tromberg (NIBIB), Steve Usdin (BioCentury) and Srikanth Vasudevan (FDA/CDRH).
Competing Interests
J. C. Goldsack is a part-time employee of HealthMode. E.S. Izmailova is an employee of Koneksa Health and owns company stock. P. M. A. Groenen is an employee of Idorsia Pharmaceuticals and owns company stock. J.A. Wagner is an employee of Foresite Capital and a member of the FNIH Biomarkers Consortium executive committee.
