TY - JOUR
T1 - Progress Versus Precision
T2 - Challenges in Clinical Trial Design for Left Ventricular Assist Devices
AU - Parides, Michael K.
AU - Moskowitz, Alan J.
AU - Ascheim, Deborah D.
AU - Rose, Eric A.
AU - Gelijns, Annetine C.
N1 - Funding Information:
This work was supported in part by a Specialized Center of Clinically Oriented Research Program Award (P50 HL077096) from the National Heart, Lung, and Blood Institute of the National Institutes of Health. The International Center for Health Outcomes and Innovation Research of Columbia University received research support from Ventracor Limited (Chatswood, New South Wales, Australia) and Micromed Technology (Houston, Texas). The opinions are solely those of the authors.
PY - 2006/9
Y1 - 2006/9
N2 - New left ventricular assist devices promise fewer adverse events but, currently, only minor improvements in survival. Small (survival) treatment effects, limited patient populations, and the increasing number of left ventricular assist devices in development challenge the efficient conduct of premarketing trials (especially in destination therapy) and, maybe more importantly, hamper innovation. Novel trial designs would facilitate this process. Among a range of trial designs, we opt for small randomized trials, which would preserve the advantages of randomization and also allow for a shorter enrollment period. We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure.
AB - New left ventricular assist devices promise fewer adverse events but, currently, only minor improvements in survival. Small (survival) treatment effects, limited patient populations, and the increasing number of left ventricular assist devices in development challenge the efficient conduct of premarketing trials (especially in destination therapy) and, maybe more importantly, hamper innovation. Novel trial designs would facilitate this process. Among a range of trial designs, we opt for small randomized trials, which would preserve the advantages of randomization and also allow for a shorter enrollment period. We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure.
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U2 - 10.1016/j.athoracsur.2006.05.123
DO - 10.1016/j.athoracsur.2006.05.123
M3 - Review article
C2 - 16928569
AN - SCOPUS:33747366081
SN - 0003-4975
VL - 82
SP - 1140
EP - 1146
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 3
ER -