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Remote Digital Monitoring for Medical Product Development

Research output: Contribution to journalReview article

Elena S. Izmailova, John A. Wagner, Nadir Ammour, Ninad Amondikar, Andrea Bell-Vlasov, Steven Berman, Dan Bloomfield, Linda S. Brady, Xuemei Cai, Roberto A. Calle, Michelle Campbell, Francesca Cerreta, Ieuan Clay, Luca Foschini, Pat Furlong, Rob Goldel, Jennifer S. Goldsack, Peter M.A. Groenen, Amos Folarin, Jill Heemskerk & 23 more Peter Honig, Matthew Hotopf, Tania Kamphaus, Daniel R. Karlin, Christopher Leptak, Qi Liu, Husseini Manji, Robert J. Mather, Joseph P. Menetski, Vaibhav A. Narayan, Elektra Papadopoulos, Bakul Patel, Bray Patrick-Lake, Jagdeep T. Podichetty, Abhishek Pratap, Laurent Servais, Diane Stephenson, Pam Tenaerts, Bruce J. Tromberg, Steve Usdin, Srikanth Vasudevan, Vadim Zipunnikov, Steven C. Hoffmann

Original languageEnglish
JournalClinical and Translational Science
DOIs
Publication statusAccepted/In press - 1 Jan 2020

King's Authors

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.

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