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DIA 2018 Global Annual Meeting


Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?

    Session Chair(s)
      Bill  Byrom, PhD

      Bill Byrom, PhD

      • Vice President, Product Strategy and Innovation
      • CRF 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)
      Willie  Muehlhausen, DVM

      Migrating to Electronic Formats: Lessons Learned from a Meta-Synthesis of Cognitive Interview Studies

      Willie Muehlhausen, DVM

      • Head of Innovation
      • ICON Clinical Research, Ireland
      Bill  Byrom, PhD

      PRO Measurement Properties Using BYOD: Conclusions from a Formal Quantitative Equivalence Study

      Bill Byrom, PhD

      • Vice President, Product Strategy and Innovation
      • CRF Health , United Kingdom
      Sarrit  Kovacs

      FDA Perspective

      Sarrit Kovacs

      • Clinical Outcome Assessments (COA) Staff, OND, CDER
      • FDA, United States