Hypotheses [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-06-19 12:32 (89 d 08:24 ago) – Posting: # 22423
Views: 838

Hi Loky do,

in addition to what Mittyri and Dr Gunasakaran wrote, a general remark about confirmatory studies:
  1. You state a null hypothesis H0 and an alternative hypothesis H1.
    In bioequivalence H0 is inequivalence – which you desire to reject.
  2. You state an appropriate statistical method, most commonly the confidence inclusion approach.
  3. You perform the study and assess #1 by #2.
    The outcome is dichotomous, i.e., either the study passed (H0 rejected) or it failed (H0 not rejected).
What you must not do: The study failed according to the planned conditions and then you change #1 and/or #2 in order to make it pass. That’s the cherry-picking Mittyri was talking about.
In simple terms: The entire \({\small{\alpha=0.05}}\) was already ‘spent’ in the original analysis. Hence, any ‘alternative’ evaluation will increase the patient’s risk, which is not acceptable.

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Helmut Schütz
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