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Digital Health Technology (DHT) Evidentiary Template - Biomarker

Problem Statement

  • No standard template for regulatory submissions for novel digital methods (DHT)

  • Leads to inconsistencies in regulatory submissions

  • Creates hurdles for both sponsors and regulators

  • Potential delays in drug development program

Why a Template

Helpful to have a template to follow and ensure that the information presented is what the agency wants to see.

  • Support innovation by providing structured approach
  • Facilitate preparation of high-quality briefing package

Development, regulatory acceptance, and adoption of digital derived endpoints take a significant amount of time.

BIO Template:

  • This document provides a template to outline evidentiary support for the successful use of a fit-for-purpose digital health technology (DHT) that measures a biomarker as an endpoint in a drug clinical trial. It is intended for use in the IND/NDA/BLA process with the FDA.
  • Standard or Novel biomarkers measured using a DHT

BIO Digital Health Technology (DHT) Evidentiary Template for Biomarkers

Draft validation framework