Statistical Methodology Used in the TAXUS ATLAS Trial

To show noninferiority required the 1-sided upper 95% confidence interval of this small difference to not exceed the pre-specified delta of 3.0%, using the methods as defined in both the study protocol and the statistical analysis plan approved by the U.S. Food and Drug Administration (FDA) before t...

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Veröffentlicht in:	Journal of the American College of Cardiology 2009-01, Vol.53 (3), p.296-297
Hauptverfasser:	Turco, Mark A., MD, FACC, FSCAI, Ormiston, John A., MBChB
Format:	Artikel
Sprache:	eng
Schlagworte:	Cardiology Cardiovascular Confidence Intervals Coronary Stenosis - therapy Drug-Eluting Stents Equipment Design Equipment Safety Humans Hypotheses Internal Medicine Randomized Controlled Trials as Topic Sensitivity and Specificity Statistical analysis Statistics as Topic Stents Treatment Outcome United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	To show noninferiority required the 1-sided upper 95% confidence interval of this small difference to not exceed the pre-specified delta of 3.0%, using the methods as defined in both the study protocol and the statistical analysis plan approved by the U.S. Food and Drug Administration (FDA) before the study began. Because the methods for data analysis in the statistical analysis plan were not detailed in the published article, we have reproduced them herein (Fig. 1).
ISSN:	0735-1097 1558-3597
DOI:	10.1016/j.jacc.2008.09.040