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How soon will digital endpoints become a cornerstone for future drug development?

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Digital technologies are revolutionizing healthcare, enabling patient-centric pharmaceutical innovation. The MOBILISED-D study validates real-world walking speed as a novel digital endpoint for regulatory acceptance.

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Area of Science:

  • Digital health technologies in pharmaceutical research.
  • Clinical trial innovation and patient-centric care.
  • Regulatory science and digital endpoints.

Background:

  • Digital technologies are transforming healthcare, fostering patient-centric innovation in pharmaceuticals.
  • Digital endpoints in clinical studies offer potential for innovation and reducing late-stage failures.
  • Regulatory agencies like the FDA are considering the use of digital endpoints.

Purpose of the Study:

  • To implement and validate real-world walking speed (RWS) as a digital endpoint.
  • To achieve regulatory acceptance for RWS as a first-in-class digital endpoint.
  • To leverage MOBILISED-D collaboration for advancing digital health in clinical trials.

Main Methods:

  • Academic-industrial collaboration (MOBILISED-D).
  • Implementation and validation of real-world walking speed (RWS) measurements.
  • Focus on patient-centric digital endpoints in clinical studies.

Main Results:

  • Previous research indicates mobility loss in older patients is a relevant disease indicator.
  • Potential for RWS to serve as a validated digital endpoint.
  • Advancing the acceptance of digital endpoints by regulatory authorities.

Conclusions:

  • Digital endpoints, such as RWS, are crucial for patient-centric pharmaceutical innovation.
  • Validation of RWS by regulatory authorities is a key objective.
  • MOBILISED-D aims to establish a precedent for digital endpoint acceptance.