Join us for the official launch of DiMe’s Integrated Evidence Plans (IEP) resources, designed to help you overcome key challenges in evidence generation and commercial adoption of digital health technologies (DHTs)!
Join us for our launch, “Unlocking impact through investment: Building the business case for digital endpoints,” on Mar. 26 at 11 a.m. ET. Learn how new resources support you in measuring ROI and building your business case for digital endpoints.
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims
Date/Time
June 16, 2022
Discussion Topic
The June DiMe Journal Club featured “Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims.”
This presentation will outline the current landscape for BYOD adoption and why there is still hesitancy in utilizing this method to capture PROs in clinical trials. It will touch upon the only publicized example of a PRO endpoint captured electronically using BYOD as a primary safety outcome in a phase 3 pivotal trial. It will conclude with the proposal to set-up a database where sponsors can transparently contribute details about the PRO endpoints they have captured using BYOD, followed by a live Q&A.
Listen in to the discussion with Florence Mowlem, PhD Director, eCOA at Medable
