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RegisterWow! [RSABE / ABEL]
Dear Helmut!
» we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country):
» Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%.
Can say only: Wow!
» we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country):
… in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.
» Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%.
Can say only: Wow!
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- ABEL: Type I Error Helmut 2020-09-28 17:12 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Wow!d_labes 2020-09-28 17:51
- ABEL: Type I Error ElMaestro 2020-09-29 10:41
- Lost in translation Helmut 2020-09-29 10:49
Ing. Helmut Schütz