Document Detail

Non-inferiority testing with a variable margin.
MedLine Citation:
PMID:  17240654     Owner:  NLM     Status:  MEDLINE    
There has been growing interest, when comparing an experimental treatment with an active control with respect to a binary outcome, in allowing the non-inferiority margin to depend on the unknown success rate in the control group. It does not seem universally recognized, however, that the statistical test should appropriately adjust for the uncertainty surrounding the non-inferiority margin. In this paper, we inspect a naive procedure that treats an "observed margin" as if it were fixed a priori, and explain why it might not be valid. We then derive a class of tests based on the delta method, including the Wald test and the score test, for a smooth margin. An alternative derivation is given for the asymptotic distribution of the likelihood ratio statistic, again for a smooth margin. We discuss the asymptotic behavior of these tests when applied to a piecewise smooth margin. A simple condition on the margin function is given which allows the likelihood ratio test to carry over to a piecewise smooth margin using the same critical value as for a smooth margin. Simulation experiments are conducted, under a smooth margin and a piecewise linear margin, to evaluate the finite-sample performance of the asymptotic tests studied.
Zhiwei Zhang
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biometrical journal. Biometrische Zeitschrift     Volume:  48     ISSN:  0323-3847     ISO Abbreviation:  Biom J     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2007-01-23     Completed Date:  2007-02-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7708048     Medline TA:  Biom J     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  948-65     Citation Subset:  IM    
Division of Biostatistics, OSB, CDRH, FDA, HFZ-550, 1350 Piccard Drive, Rockville, MD 20850, USA.
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MeSH Terms
Biometry / methods*
Computer Simulation
Controlled Clinical Trials as Topic / methods*
Data Interpretation, Statistical*
Logistic Models*
Models, Statistical
Outcome Assessment (Health Care) / methods*
Sample Size
Treatment Outcome*

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

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