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Closing clinical and regulatory science gaps for digital clinical measures

The clinical research community has rapidly embraced digital endpoints in recent years, as shown by DATAcc by DiMe’s Library of Digital Endpoints. The increasing use of new digital clinical measures emphasizes the importance of transforming the drug development process to create life-saving medications and benefit patients.

The challenge

A gap persists in the foundational clinical and regulatory science supporting the use of digital endpoints, despite:
  1. The widespread acceptance of digital endpoints by the industry;
  2. The issuance of the FDA’s final regulatory guidance; and
  3. DATAcc’s leading role in advancing the science of digital health measurement.
This gap must be addressed through further research and development efforts.

Uncovering and addressing key issues

DATAcc’s recent systematic review of over 1,200 studies assessing the state of evidence for analytical validation of digital health measurement products resulted in the following key findings:

  • The choice of reference measure is often reported poorly, lacking clarity and justification.
  • Analytical validation for digital measures related to how a subject feels, functions, or behaves often involves low-rigor reference measures with limited correspondence to the digital measures, limiting the strength of validity claims.
With novel measures focusing increasingly more on functional aspects of health, improving the methods for analytical validation in these scenarios offers a vast potential for advancement in the science around digital health.

The impact

This project establishes systematic criteria for selecting suitable reference measures for new digital clinical measures and endpoints and evaluating their performance requirements and aims to close the clinical and regulatory science gaps for adopting digital clinical measures by setting methodological standards for performance.

Our funder

We are immensely grateful to be the trusted organization for this work, funded by Arnold Ventures.


Our collaborators

We are thrilled about our Public-Private Partnership (PPP) liaison with the FDA’s Center for Drug Evaluation and Research (CDER).

The PPP liaison with CDER is a testament to our commitment to collaboration. We are thrilled to have the liaison join our project’s Statistical Advisory Committee, a curated group of experts in the life sciences with invaluable contributions, representing the diversity of our field in the digital era.

Statistical Advisory Committee

Enroll in our crash course

With the increasing use of digital tools, we must ensure that sensor-based digital health technologies (sDHTs) are fit for purpose by completing a thorough measurement quality assessment using DATAcc’s V3+ Framework.

Digital Medicine Academy®’s affordable, 30-minute course walks tech developers, clinicians, and clinical researchers through the V3+ Framework and the complete process of developing, evaluating, and deploying a safe, effective, and trustworthy digital measurement product.