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  1. Article ; Online: What we wish every investigator knew

    Sarah K. Cook / Nan Kennedy / Leslie Boone / Bethany Drury / Casey Rodweller / Mary Stroud / Sarah J. Nelson / Terri Edwards / Consuelo H. Wilkins / Paul Harris

    Journal of Clinical and Translational Science, Vol

    Top 4 recruitment and retention recommendations from the Recruitment Innovation Center

    2022  Volume 6

    Keywords Medicine ; R
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Response of the trial innovation network to the COVID-19 pandemic

    Rachel G. Greenberg / Lori Poole / Daniel E. Ford / Daniel Hanley / Harry P. Selker / Karen Lane / J. Michael Dean / Jeri Burr / Paul Harris / Consuelo H. Wilkins / Gordon Bernard / Terri Edwards / Daniel K. Benjamin

    Journal of Clinical and Translational Science, Vol

    2021  Volume 5

    Abstract: Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an ... ...

    Abstract Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods: The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned. Results: The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. Conclusions: Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
    Keywords Trial innovation network ; COVID-19 ; clinical trial ; SARS-CoV-2 ; CTSA ; Medicine ; R
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: The Trial Innovation Network Liaison Team

    Marisha E. Palm / Dixie D. Thompson / Terri Edwards / Kitt Swartz / Keith A. Herzog / Shweta Bansal / Benjamin Echalier / Kristen Clasen DeHart / Signe Denmark / Jurran L. Wilson / Sarah Nelson / Salina P. Waddy / Sarah E. Dunsmore / Jane C. Atkinson / Ken Wiley / Sara Hassani / Jamie P. Dwyer / Daniel F. Hanley / J. Michael Dean /
    Daniel E. Ford

    Journal of Clinical and Translational Science, Vol

    building a national clinical and translational community of practice

    2023  Volume 7

    Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

    Abstract In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
    Keywords Trial Innovation Network ; CTSA ; clinical trials ; team science ; community of practice ; collaboration ; Medicine ; R
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials

    Karen Lane / Marisha E. Palm / Eve Marion / Marie T. Kay / Dixie Thompson / Mary Stroud / Helen Boyle / Shannon Hillery / Angeline Nanni / Meghan Hildreth / Sarah Nelson / Jeri S. Burr / Terri Edwards / Lori Poole / Salina P. Waddy / Sarah E. Dunsmore / Paul Harris / Consuelo Wilkins / Gordon R. Bernard /
    J. Michael Dean / Jamie Dwyer / Daniel K. Benjamin / Harry P. Selker / Daniel F. Hanley / Daniel E. Ford

    Journal of Clinical and Translational Science, Vol

    Innovations and principles for implementing multicenter trials from the Trial Innovation Network

    2023  Volume 7

    Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

    Abstract One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
    Keywords Multicenter trials ; informative trials ; Trial Innovation Network ; study planning ; clinical trial budgets ; clinical trial resources ; Medicine ; R
    Subject code 650
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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