Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories. Endorsed by the American College of Cardiology Foundation

Pamela S. Douglas, Jeanne M. DeCara, Richard B. Devereux, Shelly Duckworth, Julius M. Gardin, Wael A. Jaber, Annitta J. Morehead, Jae K. Oh, Michael H. Picard, Scott D. Solomon, Kevin Wei, Neil J. Weissman

    Research output: Contribution to journalReview article

    119 Scopus citations

    Abstract

    The improvement of echocardiographic imaging in clinical trials research requires optimal core lab practices but goes beyond these to include all stakeholders in the research process: sponsors, trialists, clinical sites, information technology specialists, statisticians, regulators, and imagers. In this expert consensus document, we have outlined the roles and responsibilities of core labs, their relationships to other components of the trial, and, most important, procedures by which ECLs can optimize results and improve the accuracy and precision of the information they provide to parent studies. This has been shown prospectively to improve the efficiency and quality of clinical research. It is hoped that these best practices are broad enough to be applicable to other forms of cardiovascular imaging, if not all imaging used in clinical trials research.

    Original languageEnglish (US)
    Pages (from-to)755-765
    Number of pages11
    JournalJournal of the American Society of Echocardiography
    Volume22
    Issue number7
    DOIs
    StatePublished - Jul 1 2009

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    ASJC Scopus subject areas

    • Radiology Nuclear Medicine and imaging
    • Cardiology and Cardiovascular Medicine

    Cite this

    Douglas, P. S., DeCara, J. M., Devereux, R. B., Duckworth, S., Gardin, J. M., Jaber, W. A., Morehead, A. J., Oh, J. K., Picard, M. H., Solomon, S. D., Wei, K., & Weissman, N. J. (2009). Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories. Endorsed by the American College of Cardiology Foundation. Journal of the American Society of Echocardiography, 22(7), 755-765. https://doi.org/10.1016/j.echo.2009.05.020