Helmut
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Vienna, Austria,
2020-09-28 17:12
(29 d 17:10 ago)

Posting: # 21947
Views: 356
 

 ABEL: Type I Error [RSABE / ABEL]

Dear all,

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 full replicate in 24 subjects) to 45%.

Dif-tor heh smusma 🖖
Helmut Schütz
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d_labes
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Berlin, Germany,
2020-09-28 17:51
(29 d 16:31 ago)

@ Helmut
Posting: # 21948
Views: 315
 

 Wow!

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 full replicate in 24 subjects) to 45%.

Can't say only: Wow! :clap:

Regards,

Detlew
ElMaestro
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Belgium?,
2020-09-29 10:41
(28 d 23:42 ago)

@ Helmut
Posting: # 21949
Views: 270
 

 ABEL: Type I Error

» .... (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.


That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes :-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
Helmut
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Vienna, Austria,
2020-09-29 10:49
(28 d 23:33 ago)

@ ElMaestro
Posting: # 21950
Views: 265
 

 Lost in translation

Hi ElMastro,

» »

… it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


» That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes :-)

Not quite. :-D
Just before the mentioned text it read:

… no confirmation is provided that variability in the reference drug exists and is not caused by emissions; please provide confirmation in the form of an emissions estimate.

We guessed that outliers were meant by “emissions”.

Dif-tor heh smusma 🖖
Helmut Schütz
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