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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

Watch the recording

View the presentation slides

Read the publication

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