{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:30:45Z","timestamp":1790728245163,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:p>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\u2010of\u2010concept trial, part of the Trials@Home project. RADIAL was a multicenter, low\u2010intervention 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\u2010party providers. Moreover, integrating third\u2010party 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\u2010party engagements. Addressing these operational considerations will facilitate smoother transitions toward decentralized clinical research models, maximizing their potential benefits while managing associated complexities effectively\u2014especially for clinical site staff.<\/jats:p>","DOI":"10.1002\/cpt.70075","type":"journal-article","created":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T05:49:47Z","timestamp":1759384187000},"page":"1057-1066","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities\u2013Findings From the Trials@Home\n                    <scp>RADIAL<\/scp>\n                    Proof\u2010of\u2010Concept Trial"],"prefix":"10.1002","volume":"118","author":[{"given":"Katarzyna","family":"Lipinska","sequence":"first","affiliation":[{"name":"Julius Clinical Research  Zeist The 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UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvonne","family":"van Rijswick","sequence":"additional","affiliation":[{"name":"Julius Clinical Research  Zeist The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4472-4468","authenticated-orcid":false,"given":"Diederick E.","family":"Grobbee","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care University Medical Center Utrecht  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1463-8243","authenticated-orcid":false,"given":"Mira G.P.","family":"Zuidgeest","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care University Medical Center Utrecht  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Trials@Home 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Accessed June 17 2025."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.70070"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2025.104309"},{"key":"e_1_2_10_16_1","volume-title":"Guideline for Good Clinical Practice ICH E6(R3)","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use","year":"2025"},{"key":"e_1_2_10_17_1","volume-title":"Guidance on conduct of clinical trials of medical products during COVID\u201019 public health emergency: guidance for industry, investigators, and institutional review boards","author":"United States Food and Drug Administration","year":"2020"},{"key":"e_1_2_10_18_1","volume-title":"Recommendation Paper on Decentralised Clinical Trials","author":"European Medicines Agency","year":"2022"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.622"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-019-00006-4"},{"key":"e_1_2_10_21_1","unstructured":"Gardarsdottir H.et al.Regulatory interactions and learnings\u00a0\u2013 RADIAL the Trials@Home proof\u2010of\u2010concept trial on decentralization. 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