Navigating the challenges of initiating pediatric device trials – a case study

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dc.citation.articleNumbere97en_US
dc.citation.issueNumber1en_US
dc.citation.journalTitleJournal of Clinical and Translational Scienceen_US
dc.citation.volumeNumber8en_US
dc.contributor.authorHunter, R. Brandonen_US
dc.contributor.authorWillson, Richard C.en_US
dc.contributor.authorHaridas, Balakrishnaen_US
dc.contributor.authorLuk, Christineen_US
dc.contributor.authorToman, Karaen_US
dc.contributor.authorHeffernan, Michael J.en_US
dc.contributor.authorFischer, Gwenythen_US
dc.contributor.authorWettergreen, Matthewen_US
dc.contributor.authorKoh, Chester J.en_US
dc.date.accessioned2024-08-29T21:11:48Zen_US
dc.date.available2024-08-29T21:11:48Zen_US
dc.date.issued2024en_US
dc.description.abstractIntroduction:Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device.Methods:This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial. We identified key factors contributing to delays in clinical trial execution and potential best practices to expedite the process while maintaining safety, ethics, and efficacy.Results:The total time from site contact to first patient enrollment averaged 14 months. CTA and budget negotiations were the most time-consuming processes, averaging nearly 10 and 9 months, respectively. Reliance and local IRB processing also contributed significantly to the timeline, overall adding an average of 6.5 months across institutions. Nearly half of all costs were devoted to regulatory oversight. The COVID-19 pandemic caused significant slowdowns and delays at multiple institutions during study enrollment. Despite these pandemic-induced delays, it is important to note that the issues and themes highlighted remain relevant and have post-pandemic applicability.Conclusions:Our case study results underscore the importance of establishing efficient and standardized processing of CTAs, budget negotiations, and use of reliance IRBs to expedite clinical trial execution for pediatric devices. The findings also highlight the need for a national clinical trials network to streamline the clinical trial process.en_US
dc.identifier.citationHunter, R. B., Willson, R. C., Haridas, B., Luk, C., Toman, K., Heffernan, M. J., Fischer, G., Wettergreen, M., & Koh, C. J. (2024). Navigating the challenges of initiating pediatric device trials – a case study. Journal of Clinical and Translational Science, 8(1), e97. https://doi.org/10.1017/cts.2024.539en_US
dc.identifier.digitalnavigating-the-challenges-of-initiating-pediatric-device-trials-a-case-studyen_US
dc.identifier.doihttps://doi.org/10.1017/cts.2024.539en_US
dc.identifier.urihttps://hdl.handle.net/1911/117738en_US
dc.language.isoengen_US
dc.publisherCambridge University Pressen_US
dc.rightsExcept where otherwise noted, this work is licensed under a Creative Commons Attribution (CC BY) license.  Permission to reuse, publish, or reproduce the work beyond the terms of the license or beyond the bounds of fair use or other exemptions to copyright law must be obtained from the copyright holder.en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en_US
dc.titleNavigating the challenges of initiating pediatric device trials – a case studyen_US
dc.typeJournal articleen_US
dc.type.dcmiTexten_US
dc.type.publicationpublisher versionen_US
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