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

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

    Journal of clinical and translational science

    2021  Volume 5, Issue 1, Page(s) e100

    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 ... ...

    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.
    Language English
    Publishing date 2021-04-20
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2021.782
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

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

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e131

    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.
    Language English
    Publishing date 2023-05-25
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.560
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Percutaneous perfusion monitoring for the detection of hemodialysis induced cardiovascular injury.

    Penny, Jarrin D / Grant, Claire / Salerno, Fabio / Brumfield, Anne / Mianulli, Marcus / Poole, Lori / Mcintyre, Christopher W

    Hemodialysis international. International Symposium on Home Hemodialysis

    2018  Volume 22, Issue 3, Page(s) 351–358

    Abstract: Introduction: The safe delivery of hemodialysis (HD) faces dual challenges; the accurate detection of systemic circulatory stress producing cardiovascular (CV) injury, and the ability to enable effective preemptive intervention for such injury. We ... ...

    Abstract Introduction: The safe delivery of hemodialysis (HD) faces dual challenges; the accurate detection of systemic circulatory stress producing cardiovascular (CV) injury, and the ability to enable effective preemptive intervention for such injury. We performed a pilot study to examine the capability of a new noninvasive, real-time monitoring system to detect the deleterious effects of HD on CV stability.
    Methods: Eight patients were evaluated with echocardiography prior to the initiation of HD and again at peak HD stress. Continuous CV physiologic monitoring was performed throughout using oximeter-based pulse waveform analysis (CVInsight
    Findings: A reduction in pulse strength (PS) of ≥40% detected by CVI was associated with the development of RWMA (P = 0.005). This reduction occurred in 6/8 patients, all of whom exhibited myocardial stunning. Two patients had no significant reduction in PS nor evidence of myocardial stunning. In subjects with cardiac stunning, the decrease in PS was evident early during HD, 11.49 ± 10 minutes into HD treatment, prior to the detection of RWMA, which were assessed at peak HD stress, mean 210 ± 16.43 minutes into HD treatment.
    Discussion: Percutaneous perfusion monitoring, using pulse wave analysis, appears to be useful in identifying circulatory stress during HD and predicting the development of HD-induced myocardial stunning with a lead time long enough to consider timely intervention.
    MeSH term(s) Cardiovascular Diseases/etiology ; Cardiovascular Diseases/pathology ; Cardiovascular Diseases/therapy ; Echocardiography ; Female ; Humans ; Kidney Failure, Chronic/therapy ; Male ; Middle Aged ; Myocardial Stunning/physiopathology ; Percutaneous Coronary Intervention/methods ; Renal Dialysis/methods
    Language English
    Publishing date 2018-01-23
    Publishing country Canada
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2192458-2
    ISSN 1542-4758 ; 1492-7535
    ISSN (online) 1542-4758
    ISSN 1492-7535
    DOI 10.1111/hdi.12632
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 6091: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

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

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e170

    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.
    Language English
    Publishing date 2023-07-25
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.597
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network.

    Pan, Jeng-Jong / Nahm, Meredith / Wakim, Paul / Cushing, Carol / Poole, Lori / Tai, Betty / Pieper, Carl F

    Clinical trials (London, England)

    2009  Volume 6, Issue 1, Page(s) 67–75

    Abstract: Background: Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge ... ...

    Abstract Background: Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research.
    Purpose: In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. We describe the centralized informatics infrastructure and discuss our challenges to inform others considering such an endeavor.
    Methods: During the migration of a clinical trial network from a decentralized to a centralized data center model, descriptive data were captured and are presented here to assess the impact of centralization.
    Results: We present the framework for the informatics infrastructure and evaluative metrics. The network has decreased the time from last patient-last visit to database lock from an average of 7.6 months to 2.8 months. The average database error rate decreased from 0.8% to 0.2%, with a corresponding decrease in the interquartile range from 0.04%-1.0% before centralization to 0.01-0.27% after centralization. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial.
    Limitations: A single clinical trial network comprising addiction researchers and community treatment programs was assessed. The findings may not be applicable to other research settings.
    Conclusions: The identified informatics components provide the information and infrastructure needed for our clinical trial network. Post centralization data management operations are more efficient and less costly, with higher data quality.
    MeSH term(s) Clinical Trials as Topic/statistics & numerical data ; Data Collection ; Electronic Data Processing/methods ; Humans ; Medical Informatics/organization & administration ; National Institute on Drug Abuse (U.S.)/organization & administration ; United States
    Language English
    Publishing date 2009-03-02
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2138796-5
    ISSN 1740-7745
    ISSN 1740-7745
    DOI 10.1177/1740774508100983
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5831: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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