Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities–Findings From the Trials@Home RADIAL Proof‐of‐Concept Trial
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Le résumé fourni par la source
Decentralized clinical trials (DCTs) offer opportunities to improve trial accessibility, participant convenience, and efficiency, yet may pose significant operational challenges for clinical trial sites. This paper presents the operational insights gained from selecting, training, and supporting clinical sites within the RADIAL proof-of-concept trial, part of the Trials@Home project. RADIAL was a multicenter, low-intervention phase IV trial comparing conventional, hybrid, and fully decentralized approaches for individuals with type 2 diabetes mellitus across six European countries. Site selection involved detailed feasibility assessments evaluating operational capabilities, recruitment potential, technological readiness, and willingness to implement decentralized elements. Despite proactive training, including ongoing support via a centralized helpdesk, sites faced initial difficulties with technology management and participant onboarding. Contractual complexities were prominent, particularly regarding clearly delineating responsibilities and data handling in agreements involving third-party providers. Moreover, integrating third-party services necessitated meticulous oversight strategies and continuous stakeholder coordination to ensure regulatory compliance and efficient trial management. Our experiences underscore essential considerations for future DCT implementations: proactive stakeholder alignment; tailored, timely, and ongoing training and support; intuitive technology design informed by clinical user input; robust, centralized oversight structures; and clearly defined delegation frameworks for third-party engagements. Addressing these operational considerations will facilitate smoother transitions toward decentralized clinical research models, maximizing their potential benefits while managing associated complexities effectively-especially for clinical site staff.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities–Findings From the Trials@Home <scp>RADIAL</scp> Proof‐of‐Concept Trial
- Date Crossref
- 01/10/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Fresenius Kabi (Netherlands) pays non établi dans la noticeEntreprise
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Yulius pays non établi dans la noticeÉtablissement de santé
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Julius Clinical Research BV (Netherlands) pays non établi dans la noticeEntreprise
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University Medical Center Utrecht Julius Center for Health Sciences and Primary Care pays non établi dans la noticeÉtablissement de santé
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Sanofi (Netherlands) pays non établi dans la noticeEntreprise
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Belgian Burn Foundation pays non établi dans la noticeInstitution
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana pays non établi dans la noticeOrganisation à but non lucratif
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Sanofi (United Kingdom) pays non établi dans la noticeEntreprise
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Julius Clinical Research Zeist The Netherlands pays non établi dans la noticeÉtablissement de santé
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This trial was registered with identifier NCT05780151 in clinicaltrials.gov and under 2022-500449-26 in the CTIS clinical trial database pays non établi dans la noticeÉtablissement de santé
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Sanofi Amsterdam The Netherlands pays non établi dans la noticeInstitution
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Fortrea Bucharest Romania pays non établi dans la noticeInstitution
Fresenius Kabi (Netherlands), Yulius et Julius Clinical Research BV (Netherlands), avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.