Flawed evaluation accepted [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-31 14:17 2a02:8388:6bc2:ce80:59da:2536:a4ac:85cd – Posting: # 21120
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Hi Mikalai,

» I would like to stress out again that this decision tree has been used in multiple accepted BE studies. The tree is used not only by Indian CROs but CROs from developed countries. […] And again no complaints from regulators at all; otherwise, it would not be used

Sad, so sad! (Mr Trump)

» Why is it flawed?

It is [image] not even wrong. ([image] Wolfgang Pauli)

» They passed bioequivalence with the first step and did not go to the second one.

By luck because the CV was lower than assumed (30% instead of 32%) and there were substantially fewer dropouts than anticipated.

» It may be risky according to your approach but they were lucky enough. There is no TIE inflation in their study as I understand.
» What is wrong in relation to TIE inflation?

One should never design a study relying on luck!
If with this approach (assessing ABE with a 90% CI first) one proceeds to ABEL because ABE failed, the patient’s risk is compromised and there is no bloody way to control the Type I Error.
If regulators don’t give a shit about the patient’s risk, we should.

Cheers,
Helmut Schütz
[image]

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