treatment effect p<0.05 [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2009-08-20 17:12 (6143 d 12:20 ago) – Posting: # 4080
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Dear Madhura!

From the metrics you mentioned I guess you are talking about FDA's requirements? Anyhow, in bioequivalence testing for a treatment effect does not make sense (we have abandoned this concept 20 years ago).
A significant treatment effect can have many causes (and combinations of them). Basically the first three of the following go back to the sample size (which was estimated in study planing based on expected CVintra, T/R-ratio, dropout-rate):
  1. lower CVintra,
  2. T/R closer to one,
  3. lower dropout-rate,
  4. pure chance (if you test at α 0.05, you will get a significant effect in 1/20 studies - although there is none).
A significant treatment effect is not a problem (and should not even mentioned in the report), unless you go to Denmark (certain drugs only). See this thread.

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