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Wednesday, June 27 • 4:00pm - 5:15pm
#386: Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-677-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Bill Byrom, PhD

Speaker

Opening Remarks
Bryan McDowell, MBA

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

PRO Measurement Properties Using BYOD: Conclusions from a Formal Quantitative Equivalence Study
Bill Byrom, PhD

A Regulatory Perspective on BYOD
Sarrit Kovacs


Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcome Assessments (COA) Staff, OND, CDER, FDA
Sarrit Kovacs, PhD is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at FDA. Sarrit has nearly 20 years of social science research experience and is a consultant to CDER and other... Read More →
BM

Bryan McDowall

Global Program Lead, Executive Director Digital Development, Novartis Pharma AG
avatar for Bryan McDowell

Bryan McDowell

Global Program Lead, Digital Development, Novartis Pharma AG
Since starting in the pharmaceutical industry over 20 years ago Bryan and throughout this time, he has identified and pushed for the greater use of technologies to build solutions for smarter drug development programs and trials that reduce patient, site and sponsor burden while improving... Read More →
avatar for Willie Muehlhausen

Willie Muehlhausen

Head of Innovation, ICON Clinical Research
Willie Muehlhausen started his career as a Veterinary Surgeon in Berlin, Germany, before he joined the industry in March 1998. He worked for various companies in the CRO and eClinical technology space in Germany, USA, UK and Ireland. Patient Reported Outcomes were always part of this... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm EDT
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session