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

Exploring opportunities to enhance clinical trial designs by integrating remote digital monitoring technologies

The Problem
Remote digital monitoring technologies allow researchers conducting clinical trials to gather patient data while patients are outside of the clinic. Because these technologies are so new, researchers must agree on how and when to use them.
The Solution
This workshop convened stakeholders from across the drug development landscape to analyze use cases and establish standards for using remote sensing technologies in clinical trials.

Overview

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

The use of remote digital monitoring technologies (smartphone apps, wearables, ingestibles, implantables and mobile-device-based tools) has sparked the interest of consumers, providers and researchers as a new way to improve therapeutic research and development. This workshop provided a venue to address challenges and opportunities surrounding the use of remote sensing technologies to improve the probability of success in drug development and therapeutic clinical trials. 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. The workshop relied on a series of case studies, presentations and open panel sessions (available via the links below) to address key elements in evaluating the maturity of digitally measured biomarkers and defining future directions to enable a broader adoption of digital tools in human research.

 

Workshop participants identified a framework to guide the process of developing remote monitoring measures and prioritized a list of high-impact endpoints or measures that can be recorded through mobile sensing. The workshop planning team incorporated the insights from the meeting into multiple manuscripts and core recommendations to enable a framework for the analytical and clinical validation needed for drug developers and to develop and improve operational/regulatory guidance.

FNIH Contacts

Presentations from the Workshop

Workshop Goals

  • Convene diverse stakeholders in the field of digital health technology to establish a shared vocabulary for regulatory purposes.
  • Present and examine real-world case studies of remote monitoring in clinical trials to highlight concepts that may require development of a new vocabulary.
  • Identify areas of high unmet medical need that could be addressed using digital system technologies.
  • Align stakeholders to apply an evidence-based framework for the use of digital health technologies in therapeutic research and development.

Results & Accomplishments

  • Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis. Izmailova EA, Wood WA, Liu Q, et al. Digital Biomarkers (2021) 5, 103-113. https://doi.org/10.1159/000515110
  • Remote digital monitoring in clinical trials in the time of COVID-19. Goldsack JC, Izmailova ES, Menetski JP, Hoffmann SC, Groenen PM, Wagner JA. Nature Reviews Drug Discovery 19, 378-379 (2020). doi: https://www.nature.com/articles/d41573-020-00094-0
  • Remote Digital Monitoring for Medical Product Development. Izmailova EA, Wagner JA, Ammour N, et al. Clin Transl Sci (2020) 0, 1–8. doi: https://doi.org/10.1111/cts.12851

Reference Materials

Guidance Documents

Scientific Publications