TY - JOUR
T1 - Echocardiographic Imaging in Clinical Trials
T2 - American Society of Echocardiography Standards for Echocardiography Core Laboratories. Endorsed by the American College of Cardiology Foundation
AU - Douglas, Pamela S.
AU - DeCara, Jeanne M.
AU - Devereux, Richard B.
AU - Duckworth, Shelly
AU - Gardin, Julius M.
AU - Jaber, Wael A.
AU - Morehead, Annitta J.
AU - Oh, Jae K.
AU - Picard, Michael H.
AU - Solomon, Scott D.
AU - Wei, Kevin
AU - Weissman, Neil J.
PY - 2009/7
Y1 - 2009/7
N2 - 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.
AB - 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.
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U2 - 10.1016/j.echo.2009.05.020
DO - 10.1016/j.echo.2009.05.020
M3 - Review article
C2 - 19560654
AN - SCOPUS:67649085911
SN - 0894-7317
VL - 22
SP - 755
EP - 765
JO - Journal of the American Society of Echocardiography
JF - Journal of the American Society of Echocardiography
IS - 7
ER -