Significant effects: Don’t worry, be happy! [General Statistics]
❝ Could somebody help me with my doubts about significant sequence/treatment/period
❝ effects in BE study?
Search the forum for sequence effect, treatment effect, and period effect. Lots of posts, references, etc. See also the articles about carryover and a significant treatment effect.
❝ My СI-s are within the range of 80.000% - 125.000%, so formally BE acceptance criterion is met.
Excellent. Open a bottle of champagne.
❝ But these p-values scare me...
❝ I don't have much experience in BE and I think it is not good then period or sequence factor influences PK-parameter.
- Unless the the study was extremely imbalanced (say, almost all subjects in one sequence and the rest in the other), period effects mean out, since both T and R are affected to the same extent. Nothing to worry about.
- Sequence effects (actually unequal carry-over) cannot be “corrected” by a statistical method – only avoided by design (sufficiently long washout). It was shown in a large meta-analysis that in properly designed studies a significant effect is seen in ~ the level of the test and hence, likely is a statistical artifact (false positive). Forget it.
- Even a significant treatment effect is not important. Only the CI-inclusion counts.
- The fact that subjects differ is trivial. Only if you don’t see a significant effect you should start to worry (monozygotic twins or triplets in the study?) because it would violate the assumption of independence.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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