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RegisterSignificant effects: Don’t worry, be happy! [General Statistics]
posted by Helmut 
– Vienna, Austria, 2020-12-22 16:27 (298 d 17:27 ago) – Posting: # 22154
Views: 910
Hi Moloko,
» 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.
See also here and there.
» 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) can not 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.
See also here and there.
—
Dif-tor heh smusma 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Significant effects Moloko 2020-12-22 11:41 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significant effects: Don’t worry, be happy!Helmut 2020-12-22 16:27
- Significant effects: Don’t worry, be happy! Moloko 2020-12-23 13:24
- Significant effects: Don’t worry, be happy!Helmut 2020-12-22 16:27
Ing. Helmut Schütz