Aman Thukral, Kelsey Linsmeier, Brooks Fowler, Sanjay Bhardwaj
{"title":"Bring Your Own Device (BYOD): A practical framework to leverage in the electronic patient-reported outcomes(ePRO) data collection in clinical trials","authors":"Aman Thukral, Kelsey Linsmeier, Brooks Fowler, Sanjay Bhardwaj","doi":"10.47912/jscdm.110","DOIUrl":null,"url":null,"abstract":"Patient-reported outcomes (PROs) are used in pharmaceuticaltrials to obtain trends in health status. Companies commonly provision tabletand smartphone devices to collect PRO information. Alternatively, the BringYour Own Device (BYOD) model allows patients to leverage personal devices andis actively being explored as a solution. This article investigates thepotential benefits of BYOD and outlines a framework of considerations. Theframework addresses current challenges and proposes potential solutions toMeasurement Equivalence, Technical, and Operational concerns. BYOD has not yet beenimplemented on any studies for regulatory submission. Nonetheless, there isreason to believe the model will gain traction in the coming years. With theprovided framework, sponsors can assess whether the BYOD model is right for theconsidered study.","PeriodicalId":440423,"journal":{"name":"Journal of the Society for Clinical Data Management","volume":"63 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Society for Clinical Data Management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.47912/jscdm.110","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Patient-reported outcomes (PROs) are used in pharmaceuticaltrials to obtain trends in health status. Companies commonly provision tabletand smartphone devices to collect PRO information. Alternatively, the BringYour Own Device (BYOD) model allows patients to leverage personal devices andis actively being explored as a solution. This article investigates thepotential benefits of BYOD and outlines a framework of considerations. Theframework addresses current challenges and proposes potential solutions toMeasurement Equivalence, Technical, and Operational concerns. BYOD has not yet beenimplemented on any studies for regulatory submission. Nonetheless, there isreason to believe the model will gain traction in the coming years. With theprovided framework, sponsors can assess whether the BYOD model is right for theconsidered study.