Wow! [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2020-09-28 17:51 (298 d 22:09 ago) – Posting: # 21948
Views: 653

Dear Helmut!

» we know for a good while that under certain conditions the type I error 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! :clap:

Regards,

Detlew

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