"Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?

Therapeutic Innovation & Regulatory Science
Chad J GwaltneyJennifer Ross

Abstract

Field-based patient-reported outcome (PRO) assessments, including measures of signs, symptoms, and events that are administered outside of the research clinic, can be critical in evaluating the efficacy and safety of new medical treatments. Collection of this type of data commonly involves providing subjects with stand-alone electronic devices, such as smartphones, that they can use to respond to assessments in their home or work environment. Although this approach has proven useful, it is also limited in several ways: For example, provisioning stand-alone devices can be costly for sponsors, and requiring subjects to carry a device that is exclusively dedicated to the study can be burdensome. The "Bring Your Own Device" (BYOD) approach, in which subjects use their own smartphone or Internet-enabled device to complete field-based PRO assessments, addresses many of these concerns. However, the BYOD model has its own limitations that should be considered. In this article, representatives of the ePRO Consortium review operational, privacy/security, and scientific/regulatory considerations regarding BYOD. We hope that this review will allow researchers to make informed decisions when choosing methods to collect field-based PRO data ...Continue Reading

References

May 23, 2002·BMJ : British Medical Journal·Arthur A StoneMichael R Hufford
Dec 14, 2004·Controlled Clinical Trials·Karsten LauritsenIngela Wiklund
Sep 24, 2005·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Agota SzendeDennis Revicki
Nov 11, 2009·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Stephen Joel CoonsUNKNOWN ISPOR ePRO Task Force
Mar 1, 2012·International Journal of Chronic Obstructive Pulmonary Disease·Thomas GlaabRoland Buhl
Mar 14, 2013·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Silvy da Rocha DiasFrancesco Pignatti
Sep 18, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Bruce E StroberMark Lebwohl
Nov 23, 2013·Journal of Clinical Epidemiology·Jakob B BjornerJohn E Ware
Aug 8, 2014·JMIR MHealth and UHealth·Jacki LiddleHelen J Chenery
Aug 17, 2014·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Sonya EremencoUNKNOWN ISPOR PRO Mixed Modes Task Force

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Citations

Jan 8, 2019·The Clinical Neuropsychologist·Laura GermineNaomi S Chaytor
Jul 21, 2020·Circulation. Cardiovascular Quality and Outcomes·John J WarnerUNKNOWN American Heart Association Partnering with Regulators Learning Collaborative*
Nov 25, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Fiona KennedyGalina Velikova

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