Journal article
Trials and Tribulations of Noninferiority: The Ximelagatran Experience
Journal of the American College of Cardiology, v 48(5), pp 1058-1058
05 Sep 2006
PMID: 16949503
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
In many ways, the study traces the arguments in the U.S. Food and Drug Administration statistical review leading to rejection of the ximelagatran marketing application by the agency last year. Neglecting SPORTIF III and the pooled results overlooks not only the hard end points, blinded evaluations, and exhaustive measures to minimize bias, but also neglects the generalizability of observations to clinical practice.
Metrics
Details
- Title
- Trials and Tribulations of Noninferiority: The Ximelagatran Experience
- Creators
- Gregory AlbersHans-Christoph DienerLars FrisonMargaretha GrindJay HorrowMark NevinsonS OlssonStephen PartridgePalle PetersenAlec VahanianJonathan HalperinExecutive Steering Committee for the SPORTIF III and V Investigators
- Publication Details
- Journal of the American College of Cardiology, v 48(5), pp 1058-1058
- Publisher
- Elsevier Limited
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Anesthesiology and Perioperative Medicine
- Web of Science ID
- WOS:000240324500025
- Scopus ID
- 2-s2.0-33747880684
- Other Identifier
- 991020785618604721
UN Sustainable Development Goals (SDGs)
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems