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  1. 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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  2. Article ; Online: Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19

    Leon Di Stefano / Elizabeth L Ogburn / Malathi Ram / Daniel O Scharfstein / Tianjing Li / Preeti Khanal / Sheriza N Baksh / Nichol McBee / Joshua Gruber / Marianne R Gildea / Megan R Clark / Neil A Goldenberg / Yussef Bennani / Samuel M Brown / Whitney R Buckel / Meredith E Clement / Mark J Mulligan / Jane A O'Halloran / Adriana M Rauseo /
    Wesley H Self / Matthew W Semler / Todd Seto / Jason E Stout / Robert J Ulrich / Jennifer Victory / Barbara E Bierer / Daniel F Hanley / Daniel Freilich / Pandemic Response COVID-19 Research Collaboration Platform for HCQ/CQ Pooled Analyses

    PLoS ONE, Vol 17, Iss 9, p e

    An individual participant data meta-analysis.

    2022  Volume 0273526

    Abstract: Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, ... ...

    Abstract Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. Methods We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Results Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.
    Keywords Medicine ; R ; Science ; Q
    Subject code 310
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

    More links

    Kategorien

    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.

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