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Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?
Session Chair(s)
Bill Byrom, PhD
Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Signant Health , United Kingdom
In this session we review recent published work and how this impacts our view on the use of Bring Your Own Device (BYOD) for electronic collection of patient-reported outcome (ePRO) data. We will report a recent meta-synthesis of cognitive interview studies conducted on over 100 PRO instruments, and how the evidence from this supports the use of ePRO and informs the evidentiary requirements when using ePRO with provisioned devices and BYOD. We will review the industry’s first definitive BYOD quantitative equivalence study conducted in 155 subjects suffering from chronic pain, and examine the implications and generalizability of this study for the wider-scale use of BYOD in clinical trials. In addition, we will hear a viewpoint on BYOD from a regulatory perspective.
Learning Objective : Appraise new evidence on the use of Bring Your Own Device (BYOD) to collect patient-reported outcomes data; Evaluate practical considerations and acceptability of the approach with sites and patients based on conducted clinical trials; Identify current regulatory views on the use of BYOD.
Speaker(s)
Opening Remarks
Bryan McDowell, MBA, MSc
Clario, Switzerland
Vice President, eCOA Clinical Science and Consulting
Migrating to Electronic Formats: Lessons Learned from a Meta-Synthesis of Cognitive Interview Studies
Willie Muehlhausen, DVM
SAFIRA Clinical Research, Ireland
Co-Founder
PRO Measurement Properties Using BYOD: Conclusions from a Formal Quantitative Equivalence Study
Bill Byrom, PhD
Signant Health , United Kingdom
Vice President, Product Intelligence and Positioning; Principal, eCOA Science
A Regulatory Perspective on BYOD
Sarrit Kovacs
FDA, United States
Clinical Reviewer, Division of Gastrenterology, OII, OND, CDER
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