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RegisterHypotheses in non-inferiority trials [Power / Sample Size]
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]
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]
Complete thread:
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- Ad hoc power The Outlaw Torn 2015-05-14 11:38
- Ad hoc power d_labes 2015-05-13 20:18
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Ing. Helmut Schütz