Hypotheses in non-inferiority trials [Power / Sample Size]

posted by arjunroy – India, 2015-06-29 10:24 (3520 d 06:58 ago) – Posting: # 14994
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Time is changing so do p-value calculations of NI, because everybody likes p-value.
Some of the publication (refer below: NEJM Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes, 2015).

Sitagliptin was noninferior to placebo for the primary composite
cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001).
Though hazard ration includes 1 however p-value for the test of non-inferiority was noted significant.
The P value is for the noninferiority of sitagliptin, as compared with placebo, which was calculated by determining whether the upper boundary of the two-sided 95% confidence interval of the hazard ratio exceeded 1.30.
Hope this helps.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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