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  1. Article ; Online: Decentralized research technology use in multicenter clinical research studies based at U.S. academic research centers

    Mollie R. Cummins / Jeri Burr / Lisa Young / Sharon D. Yeatts / Dixie J. Ecklund / Brian E. Bunnell / Jamie P. Dwyer / John M. VanBuren

    Journal of Clinical and Translational Science, Vol

    2023  Volume 7

    Abstract: Abstract Introduction: During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there’s a pressing need to evaluate current decentralization practices and develop appropriate ... ...

    Abstract Abstract Introduction: During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there’s a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs). Methods: The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies. Results: We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98–100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%). Conclusions: All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.
    Keywords Biomedical research ; clinical research informatics ; informatics ; data coordinating centers ; decentralized trials ; decentralized research ; digital health ; Medicine ; R
    Subject code 690
    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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  2. Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network

    Marisha E. Palm / Terri L. Edwards / Cortney Wieber / Marie T. Kay / Eve Marion / Leslie Boone / Angeline Nanni / Michelle Jones / Eilene Pham / Meghan Hildreth / Karen Lane / Nichol McBee / Daniel K. Benjamin / Gordon R. Bernard / J. Michael Dean / Jamie P. Dwyer / Daniel E. Ford / Daniel F. Hanley / Paul A. Harris /
    Consuelo H. Wilkins / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    2023  Volume 7

    Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

    Abstract Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
    Keywords Trial innovation network ; CTSA ; clinical trials ; clinical trial roadblocks ; innovation ; 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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  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: Decentralized clinical trials in the trial innovation network

    Daniel F. Hanley / Gordon R. Bernard / Consuelo H. Wilkins / Harry P. Selker / Jamie P. Dwyer / J. Michael Dean / Daniel Kelly Benjamin / Sarah E. Dunsmore / Salina P. Waddy / Kenneth L. Wiley / Marisha E. Palm / W. Andrew Mould / Daniel F. Ford / Jeri S. Burr / Jacqueline Huvane / Karen Lane / Lori Poole / Terri L. Edwards / Nan Kennedy /
    Leslie R. Boone / Jasmine Bell / Emily Serdoz / Loretta M. Byrne / Paul A. Harris

    Journal of Clinical and Translational Science, Vol

    Value, strategies, and lessons learned

    2023  Volume 7

    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 ... ...

    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.
    Keywords Decentralized trials ; hybrid trials ; CTSA ; trial innovation network ; inclusive recruitment ; remote trials ; remote technology ; rural recruitment ; remote recruitment ; remote intervention ; remote data collection ; MyCap ; remote trial monitoring ; Medicine ; R
    Subject code 610
    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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    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  5. Article ; Online: Pulse wave velocity and central aortic pressure in systolic blood pressure intervention trial participants.

    Mark A Supiano / Laura Lovato / Walter T Ambrosius / Jeffrey Bates / Srinivasan Beddhu / Paul Drawz / Jamie P Dwyer / Naomi M Hamburg / Dalane Kitzman / James Lash / Eva Lustigova / Cynthia M Miracle / Suzanne Oparil / Dominic S Raj / Daniel E Weiner / Addison Taylor / Joseph A Vita / Reem Yunis / Glenn M Chertow /
    Michel Chonchol

    PLoS ONE, Vol 13, Iss 9, p e

    2018  Volume 0203305

    Abstract: Arterial stiffness, typically assessed as the aortic pulse wave velocity (PWV), and central blood pressure levels may be indicators of cardiovascular disease (CVD) risk. This ancillary study to the Systolic Blood Pressure Intervention Trial (SPRINT) ... ...

    Abstract Arterial stiffness, typically assessed as the aortic pulse wave velocity (PWV), and central blood pressure levels may be indicators of cardiovascular disease (CVD) risk. This ancillary study to the Systolic Blood Pressure Intervention Trial (SPRINT) obtained baseline assessments (at randomization) of PWV and central systolic blood pressure (C-SBP) to: 1) characterize these vascular measurements in the SPRINT cohort, and 2) test the hypotheses that PWV and C-SBP are associated with glucose homeostasis and markers of chronic kidney disease (CKD). The SphygmoCor® CPV device was used to assess carotid-femoral PWV and its pulse wave analysis study protocol was used to obtain C-SBP. Valid results were obtained from 652 participants. Mean (±SD) PWV and C-SBP for the SPRINT cohort were 10.7 ± 2.7 m/s and 132.0 ± 17.9 mm Hg respectively. Linear regression analyses for PWV and C-SBP results adjusted for age, sex, and race/ethnicity in relation to several markers of glucose homeostasis and CKD did not identify any significant associations with the exception of a marginally statistically significant and modest association between PWV and urine albumin-to-creatinine ratio (linear regression estimate ± SE, 0.001 ± 0.0006; P-value 0.046). In a subset of SPRINT participants, PWV was significantly higher than in prior studies of normotensive persons, as expected. For older age groups in the SPRINT cohort (age > 60 years), PWV was compared with a reference population of hypertensive individuals. There were no compelling associations noted between PWV or C-SBP and markers of glucose homeostasis or CKD. Clinical trial registration NCT01206062.
    Keywords Medicine ; R ; Science ; Q
    Subject code 796
    Language English
    Publishing date 2018-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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