Mobilise-D
Published May 12, 2023 | Version v1
Journal article Open

Reverse Engineering of Digital Measures: Inviting Patients to the Conversation

Authors/Creators

  • 1. VivoSense Inc., Newport Beach, CA, USA.
  • 2. The Foundation for the NIH, North Bethesda, MD, USA.
  • 3. PersonalPulse GmbH, Basel, Switzerland.
  • 4. Insight Centre for Data Analytics, UC Dublin, Dublin, Ireland. Mobilise-D, Newcastle University, Newcastle upon Tyne, UK.
  • 5. Quality of Life Lab, University of Geneva, Geneva, Switzerland.
  • 6. Mobilise-D, Newcastle University, Newcastle upon Tyne, UK.
  • 7. Harvard Medical School, Cambridge, MA, USA.
  • 8. Newcastle University, Newcastle, UK. IDEA-FAST, Newcastle University, Newcastle upon Tyne, UK.
  • 9. Mobilise-D, Newcastle University, Newcastle upon Tyne, UK. Polytechnic University of Torino, Torino, Italy.
  • 10. IDEA-FAST, Newcastle University, Newcastle upon Tyne, UK. Cambridge Cognition Ltd, Cambridge, UK.
  • 11. Sysnav Healthcare, Vernon, France.
  • 12. Sage Bionetworks, Seattle, WA, USA.
  • 13. SHL Medical, Zug, Switzerland.
  • 14. Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
  • 15. SMA Schweiz, Heimberg, Switzerland.
  • 16. Koneksa Health, New York, NY, USA.
  • 17. Biogen Digital Health International GmbH, Baar, Switzerland.
  • 18. F. Hoffmann-La Roche, Basel, Switzerland.
  • 19. Mobilise-D, Newcastle University, Newcastle upon Tyne, UK. Novartis, Basel, Switzerland.
  • 20. IDEA-FAST, Newcastle University, Newcastle upon Tyne, UK. F. Hoffmann-La Roche, Basel, Switzerland.
  • 21. Takeda Pharmaceuticals International, Zurich, Switzerland.
  • 22. Mobilise-D, Newcastle University, Newcastle upon Tyne, UK. Norwegian University of Science and Technology, Trondheim, Norway.
  • 23. Sibel Health, Niles, IL, USA.
  • 24. Swiss Federal Institute of Technology, Zurich, Switzerland.
  • 25. European Medicines Agency, Amsterdam, The Netherlands.

Description

Abstract

Background: Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers, and the clinical evidence used to drive drug development and disease management. Reaching this vision will require achieving a new level of co-creation between the stakeholders who design, develop, use, and make decisions using evidence from digital measures.

Summary: In September 2022, the second in a series of meetings hosted by the Swiss Federal Institute of Technology in Zürich, the Foundation for the National Institutes of Health Biomarkers Consortium, and sponsored by Wellcome Trust, entitled "Reverse Engineering of Digital Measures," was held in Zurich, Switzerland, with a broad range of stakeholders sharing their experience across four case studies to examine how patient centricity is essential in shaping development and validation of digital evidence generation tools.

Key messages: In this paper, we discuss progress and the remaining barriers to widespread use of digital measures for evidence generation in clinical development and care delivery. We also present key discussion points and takeaways in order to continue discourse and provide a basis for dissemination and outreach to the wider community and other stakeholders. The work presented here shows us a blueprint for how and why the patient voice can be thoughtfully integrated into digital measure development and that continued multistakeholder engagement is critical for further progress.

Keywords: Co-creation; Digital measures; Meeting report; Multistakeholder engagement; Patient centricity.

Notes

This work was supported by the Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820820. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication reflects the authors' view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.

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Additional details

Funding

European Commission
MOBILISE-D - Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement 820820