ABEL: Type I Error [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-09-28 19:12 (792 d 23:10 ago) – Posting: # 21947
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Dear all,

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%.

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