학술논문
Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.
Document Type
Academic Journal
Author
Hanley DF Jr; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA.; Bernard GR; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Wilkins CH; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Department of Internal Medicine, Meharry Medical College, Nashville, TN, USA.; Selker HP; Department of Medicine, Tufts University, Boston, MA, USA.; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.; Dwyer JP; University of Utah Health, Salt Lake City, UT, USA.; Utah Clinical and Translational Sciences Institute, Salt Lake City, UT, USA.; Dean JM; University of Utah Health, Salt Lake City, UT, USA.; Benjamin DK Jr; Duke University School of Medicine, Durham, NC, USA.; Duke Clinical Research Institute, Durham, NC, USA.; Dunsmore SE; National Center for Advancing Translational Sciences, Bethesda, MD, USA.; Waddy SP; National Center for Advancing Translational Sciences, Bethesda, MD, USA.; Wiley KL Jr; National Center for Advancing Translational Sciences, Bethesda, MD, USA.; Palm ME; Department of Medicine, Tufts University, Boston, MA, USA.; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.; Mould WA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins BIOS Clinical Trials Coordinating Center, Baltimore, MD, USA.; Ford DF; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA.; Burr JS; University of Utah Health, Salt Lake City, UT, USA.; Huvane J; Duke Clinical Research Institute, Durham, NC, USA.; Lane K; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA.; Poole L; Duke Clinical Research Institute, Durham, NC, USA.; Edwards TL; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Kennedy N; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Boone LR; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Bell J; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Serdoz E; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Byrne LM; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Harris PA; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.
Source
Publisher: Cambridge University Press Country of Publication: England NLM ID: 101689953 Publication Model: eCollection Cited Medium: Internet ISSN: 2059-8661 (Electronic) Linking ISSN: 20598661 NLM ISO Abbreviation: J Clin Transl Sci Subsets: PubMed not MEDLINE
Subject
Language
English
Abstract
New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Competing Interests: Dr Benjamin, Jr. reports consultancy for Allergan, Melinta Therapeutics, and Sun Pharma Advanced Research Co. The remaining authors declare no conflicts of interest.
(© The Author(s) 2023.)
Competing Interests: Dr Benjamin, Jr. reports consultancy for Allergan, Melinta Therapeutics, and Sun Pharma Advanced Research Co. The remaining authors declare no conflicts of interest.
(© The Author(s) 2023.)