Document Detail


Progress versus precision: challenges in clinical trial design for left ventricular assist devices.
MedLine Citation:
PMID:  16928569     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Michael K Parides; Alan J Moskowitz; Deborah D Ascheim; Eric A Rose; Annetine C Gelijns
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  82     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-24     Completed Date:  2006-09-13     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  1140-6     Citation Subset:  AIM; IM    
Affiliation:
International Center for Health Outcomes and Innovation Research, Columbia University, New York, New York 10032, USA.
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MeSH Terms
Descriptor/Qualifier:
Biological Markers
Clinical Trials as Topic / methods,  standards*
Control Groups
Device Approval / standards*
Equipment Design
Follow-Up Studies
Health Policy
Heart Transplantation
Heart-Assist Devices* / standards
Humans
Interinstitutional Relations
Patient Selection
Product Surveillance, Postmarketing
Quality of Life
Sample Size
Survival Analysis
United States
United States Food and Drug Administration / standards*
Ventricular Dysfunction, Left / surgery
Grant Support
ID/Acronym/Agency:
P50 HL077096/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Biological Markers
Comments/Corrections
Comment In:
Ann Thorac Surg. 2006 Sep;82(3):773-5   [PMID:  16928481 ]
Ann Thorac Surg. 2006 Sep;82(3):776-80   [PMID:  16928482 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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