Abstract:
:A randomized, active-control clinical trial setting with the objective of testing noninferiority for a continuous response variable is considered. Noninferiority margin is based on the concept of preserving a certain fraction of the active control effect. Noninferiority is established if the ratio of the lower (upper) limit of the two-sided 95% confidence interval for the treatment difference to the estimated mean of the active control is greater (less) than a certain fraction. The nominal significance level is not maintained by the above confidence interval-based noninferiority test. We use bootstrapping to derive an accurate lower (upper) limit of the same confidence interval, which approximates the nominal significance level better and improves the power.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Chen M,Kianifard F,Dhar SKdoi
10.1080/10543400600609478subject
Has Abstractpub_date
2006-05-01 00:00:00pages
357-63issue
3eissn
1054-3406issn
1520-5711journal_volume
16pub_type
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