Remote Digital Monitoring for Medical Product Development

TLDR

Digital health products are increasingly viewed as a promising avenue for therapeutic research and development, yet their uptake in clinical trials remains limited because of regulatory uncertainty and a mismatch between promised benefits and perceived risks. The study aims to harmonize definitions, develop common methodologies, integrate digital monitoring data into clinical trials, and sustain community dialogue. The authors organized a public workshop by the FNIH Biomarkers Consortium featuring presentations, case studies, and open panels to explore challenges and opportunities in digital monitoring. Participants endorsed an evidentiary criteria framework, early patient engagement, and the potential of digital monitoring tools, while noting gaps in real‑life validation, legacy standard limitations, and the need for new analytical methods; they agreed these efforts could transform clinical trial design, conduct, and regulatory review.

Abstract

The use of digital health products has gained considerable interest as a new way to improve therapeutic research and development. Although these products are being adopted by various industries and stakeholders, their incorporation in clinical trials has been slow due to a disconnect between the promises of digital products and potential risks in using these new technologies in the absence of regulatory support. The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium hosted a public workshop to address challenges and opportunities in this field. Important characteristics of tool development were addressed in a series of presentations, case studies, and open panel sessions. The workshop participants endorsed the usefulness of an evidentiary criteria framework, highlighted the importance of early patient engagement, and emphasized the potential impact of digital monitoring tools and precompetitive collaborations. Concerns were expressed about the lack of real‐life validation examples and the limitations of legacy standards used as a benchmark for novel tool development and validation. Participants recognized the need for novel analytical and statistical approaches to accommodate analyses of these novel data types. Future directions are to harmonize definitions to build common methodologies and foster multidisciplinary collaborations; to develop approaches toward integrating digital monitoring data with the totality of the data in clinical trials, and to continue an open dialog in the community. There was a consensus that all these efforts combined may create a paradigm shift of how clinical trials are planned, conducted, and results brought to regulatory reviews.