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Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward

Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported reg...

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Autores principales: Mowlem, Florence D., Tenaerts, Pamela, Gwaltney, Chad, Oakley-Girvan, Ingrid
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9084261/
https://www.ncbi.nlm.nih.gov/pubmed/35534774
http://dx.doi.org/10.1007/s43441-022-00412-1
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author Mowlem, Florence D.
Tenaerts, Pamela
Gwaltney, Chad
Oakley-Girvan, Ingrid
author_facet Mowlem, Florence D.
Tenaerts, Pamela
Gwaltney, Chad
Oakley-Girvan, Ingrid
author_sort Mowlem, Florence D.
collection PubMed
description Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however—except for one—these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.
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spelling pubmed-90842612022-05-10 Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward Mowlem, Florence D. Tenaerts, Pamela Gwaltney, Chad Oakley-Girvan, Ingrid Ther Innov Regul Sci Commentary Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however—except for one—these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity. Springer International Publishing 2022-05-09 2022 /pmc/articles/PMC9084261/ /pubmed/35534774 http://dx.doi.org/10.1007/s43441-022-00412-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Commentary
Mowlem, Florence D.
Tenaerts, Pamela
Gwaltney, Chad
Oakley-Girvan, Ingrid
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title_full Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title_fullStr Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title_full_unstemmed Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title_short Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims: Let’s Share the Success Stories to Move the Industry Forward
title_sort regulatory acceptance of patient-reported outcome (pro) data from bring-your-own-device (byod) solutions to support medical product labeling claims: let’s share the success stories to move the industry forward
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9084261/
https://www.ncbi.nlm.nih.gov/pubmed/35534774
http://dx.doi.org/10.1007/s43441-022-00412-1
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