one-sided / two-sided [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2019-03-04 01:20  – Posting: # 19996
Views: 1,352

Hi Ohlbe,

» […] So even if you test the lower limit with a 5 % risk, and the higher limit with a 5 % risk, the overall risk still remains 5 % for the patients, not 10 %.

Correct.

@Akash: Maybe you were confused by one-sided superiority testing in phase III (which is performed at an α-level of 5%). In other words, if patients are treated with the originator’s product, there is a 5% risk that it does not perform better (more efficient and/or safer) than placebo.
If we would test for BE at the 2.5% level (95% CI) we would be overly strict and at the same time gain absolutely nothing in terms of the patient’s risk.

Cheers,
Helmut Schütz
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