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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.


Session 7 Track A: Role of Public-Private Partnerships in Generating Evidence for Remote Monitoring Technologies: Rewards and Challenges

Session Chair(s)

Scottie  Kern

Scottie Kern

  • Executive Director
  • eCOA Consortium, United Kingdom
Sonya  Eremenco, MA

Sonya Eremenco, MA

  • Executive Director, PRO Consortium
  • Critical Path Institute, United States
The Critical Path Institute (C-Path) creates precompetitive public-private partnerships that bring together stakeholders to improve the process of medical product development. Several consortia within C-Path are pursuing research related to remote monitoring technologies, e.g., wearable devices or activity monitors, in order to support their use in clinical trials and research. This session will highlight two case examples: one from the Critical Path to Parkinson’s (CPP) Consortium digital drug development tool 3DT project and the other from the PRO Consortium’s Chronic Heart Failure (CHF) Working Group, which is pursuing qualification of an activity monitor-based endpoint measure by the US Food and Drug Administration’s Clinical Outcome Assessment Qualification Program. Both projects involve industry sponsors willing to collaborate to achieve regulatory endorsement of drug development tools for use in clinical trials. In both cases, individual sponsors were willing to share data from non-interventional observational studies within each consortium in order to accelerate progress toward the collective goal. The session will highlight the challenges and rewards of data sharing within each project, and why sharing of remote monitoring technology data in particular will be crucial to the long-term success of each project. The panelists for this session will include a representative of the Patient-Reported Outcome (PRO) Consortium at C-Path, who will discuss the need for data sharing to advance the effort to qualify an activity monitor-based endpoint measure in chronic heart failure, an industry representative from CPP, and an FDA representative, who will share their perspectives on the promise and the challenges of data sharing in the context of studies involving remote monitoring technologies.
Learning Objective :
  • Understand how public-private partnerships work to generate evidence to support regulatory endorsement of drug development tools for use in clinical trials
  • Explain rewards and challenges of pre-competitive collaboration and data sharing in the regulated clinical trials space
  • Identify opportunities to enhance the integration of the patient voice in advancing remote monitoring technologies

Speaker(s)

Diane  Stephenson, PhD

Critical Path to Parkinson’s (CPP) Consortium Digital Drug Development Tool 3DT Project

Diane Stephenson, PhD

  • Executive Director
  • Critical Path Institute, United States
Sonya  Eremenco, MA

Role of Public-Private Partnerships in Generating Evidence for Remote Monitoring Technologies: Rewards and Challenges

Sonya Eremenco, MA

  • Executive Director, PRO Consortium
  • Critical Path Institute, United States
Josh  Cosman, PhD

Speaker

Josh Cosman, PhD

  • Director, Digital Science
  • Abbvie, United States
Michelle  Campbell, PhD

Speaker

Michelle Campbell, PhD

  • Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
  • FDA, United States