Non-superiority [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-03-19 17:59 (4414 d 05:49 ago) – Posting: # 8299
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Dear Jaime!

❝ […] does that require the upper one-sided 95% CL included in 125% – or […] – assessing the upper limit of the 90% CI only?


Both will work.

❝ How can we calculate the sample size?


Ouch; good question! Steven Julious (Sample Sizes for Clinical Trials, 2010) gives a method for cross-over studies (actually the other way ’round: non-inferiority) but only for normal distributed data. Have to sleep over it.

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