학술논문
Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.
Document Type
Academic Journal
Author
Harris PA; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee.; Dunsmore SE; National Center for Advancing Translational Sciences, Bethesda, Maryland.; Atkinson JC; National Center for Advancing Translational Sciences, Bethesda, Maryland.; Benjamin DK Jr; Duke University School of Medicine, Durham, North Carolina.; Duke Clinical Research Institute, Durham, North Carolina.; Bernard GR; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.; Dean JM; University of Utah Health, Salt Lake City.; Dwyer JP; University of Utah Health, Salt Lake City.; Utah Clinical and Translational Sciences Institute, Salt Lake City.; Ford DF; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, Maryland.; Selker HP; Department of Medicine, Tufts University, Boston, Massachusetts.; Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts.; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.; Waddy SP; National Center for Advancing Translational Sciences, Bethesda, Maryland.; Wiley KL; National Center for Advancing Translational Sciences, Bethesda, Maryland.; Wilkins CH; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.; Department of Internal Medicine, Meharry Medical College, Nashville, Tennessee.; Cook SK; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Burr JS; University of Utah Health, Salt Lake City.; Edwards TL; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Huvane J; Duke Clinical Research Institute, Durham, North Carolina.; Kennedy N; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Lane K; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, Maryland.; Johns Hopkins University School of Medicine, Baltimore, Maryland.; Majkowski R; Johns Hopkins University School of Medicine, Baltimore, Maryland.; Nelson S; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Palm ME; Department of Medicine, Tufts University, Boston, Massachusetts.; Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts.; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.; Stroud M; Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee.; Thompson DD; University of Utah Health, Salt Lake City.; Utah Clinical and Translational Sciences Institute, Salt Lake City.; Busacca L; Irving Institute for Clinical and Translational Research, Columbia University Irving Medical Center, New York, New York.; Elkind MSV; Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York.; Kimberly RP; Center for Clinical and Translational Science, University of Alabama at Birmingham.; Reilly MP; Irving Institute for Clinical and Translational Research, Columbia University Irving Medical Center, New York, New York.; Hanley DF; Johns Hopkins Institute for Clinical and Translational Research, Baltimore, Maryland.; Johns Hopkins University School of Medicine, Baltimore, Maryland.
Source
Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE
Subject
Language
English
Abstract
Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support.
Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.
Conclusions and Relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.
Conclusions and Relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.