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Digital endpoints offer the opportunity to measure what matters to persons living with a disease, enhancing and/or replacing classical clinical outcome measures to improve the patient centricity and efficiency of medical product development, and generate more valuable information. There is evidence of increasing regulatory acceptance for the use of digital endpoints in medicine development. But how are meaningful digital endpoints identified and incorporated into a trial? And what can be done to drive their acceptance and use? For continued progress, it is important for sponsors to have access to multi-stakeholder-developed frameworks.

In this session, panelists will present several approaches that may assist with advancing the use of meaningful digital health technology derived novel endpoints in clinical trials for labeling claims. Attendees will be introduced to a number of tools to use when developing digital outcome measures.

These include: TransCelerate’s efforts to clarify concept development, validation approaches acceptable to regulators, clinical interpretations, evidentiary requirements, and global pathways in an effort to accelerate Novel Digital Endpoint (NDE) use. Illustrative case studies will be included; the Clinical Trial Transformation Inititative’s (CTTI) pathway for novel endpoint development including new work to create additional resources and recommendations to drive the use of digitally derived, functional outcomes as key endpoints in clinical trials to support regulatory decision-making; and the Digital Medicine Society’s (DiMe) open access digital endpoint library, the V3 evaluation framework for digital measurement performance, and the five part evaluation framework for digital measurement technologies. Discussion will include and how to put these resources, and more, into action today.

Learning objectives

At the conclusion of this session, participants should be able to:
  • Identify key considerations for developing novel digital endpoints for use in medical product development
  • Describe approaches to advancing the use of novel digital endpoints for use in medical product development
  • Evaluate the value of novel digital endpoints to different stakeholders including patients, clinicians, researchers, medical product developers, regulators, and payers

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