Navigating the Development of a Digitally Derived Endpoint

Overview

A collaborative workshop that brings together industry leaders, regulatory bodies, researchers, and patient groups to explore, discuss, and strategize the effective integration of Digital Measures into clinical trials and medical product development, focusing on developing a shared understanding and approach to digitally derived endpoints.

Join us on June 24th and 25th for a collaborative workshop that brings together industry leaders, regulatory bodies, researchers, and patient groups to explore, discuss, and strategize the effective integration of Digital Measures into clinical trials and medical product development, focusing on developing a shared understanding and approach to digitally derived endpoints.

Goals
  • To identify challenges and opportunities presented by Digital Measures in clinical trials and drug development.

  • To discuss strategies for evaluating and selecting Digital Measures that are fit-for-purpose.

  • To explore the current landscape of validated and FDA-approved applications of Digital Measures.

  • To encourage sharing best practices and harmonizing recommendations for Digital Measure validation and use.

Previous Workshops

On February 18 and 19, 2020, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium held a public meeting titled Remote Digital Monitoring for Medical Product Development Workshop. The purpose of this workshop was to provide a forum for discussing opportunities and issues related to remote sensing technologies to increase the likelihood that drug development and therapeutic clinical trials will be successful.

The workshop focused on critical issues in assessing the maturity of digitally measured biomarkers and identifying future paths to enable more extensive usage of digital tools in human Research. These case studies, presentations, and open panel discussions are available via the links below.

Workshop participants prioritized a list of high-impact endpoints or measures that can be recorded by mobile sensing and created a framework to direct the development of remote monitoring measures. To enable a framework for the analytical and clinical validation required for drug developers and to build and improve operational/regulatory guidelines, the workshop planning team combined the meeting’s insights into several manuscripts and significant recommendations.

The FNIH Biomarkers Consortium co-hosted a second workshop, titled “Reverse Engineering of Digital Measures,” in 2022 with ETH, a public Research university in Zurich, Switzerland. This workshop expanded on the first meeting’s success by presenting insights from four extended case studies and assessing advancements, possibilities, and difficulties. The interactive case studies highlighted how patient-centricity impacts the production and validation of new evidence across settings, including regulatory interactions, reimbursement, and product development. Participants included regulators, industry, patients, and innovators. An important outcome of the session was a greater understanding of the importance of patient-centricity in creating new digital measures.

The group looked at how human-centered, comprehensive, evidence-based science is applied in the field. As a result, they also examined how this application affects interactions with payers and regulators, patient and human engagement, product development, and incorporating digital measures into decision-making throughout healthcare delivery.

active-project-img
2020 Workshop Presentations

Remote Digital Monitoring for Medical Product Development

Learn More
active-project-img
2022 Workshop Presentations

Reverse Engineering of Digital Measures: A conference on patient-centric digital evidence

Learn More
Contact

Donate

Donate to the FNIH today to support medical research that saves lives

Partner With Us

Work with the FNIH to accelerate medical breakthroughs for patients