Flawed approach even if accepted ? [RSABE / ABEL]

posted by Mikalai  – Belarus, 2020-02-01 17:18 (1540 d 04:30 ago) – Posting: # 21125
Views: 18,895

(edited by Mikalai on 2020-02-01 17:33)

Dear Helmut

❝ Seems that your line of argument is a financial one (though veiled behind words like taxpayer’s money). I’m interested in the patient’s risk – possibly more than some regulators.

I am not fighting for money but for democracy, the Republic...

Your approach is nothing more than a road to hell lined with good intentions.

Basically you advocate rejecting trials because of things that are neither legally prohibited nor have happened but are/were (when trials done) risky from one scientific angle. I guess this practice hardly only one that is so contentious in the industry. Your approach basically gives experts the power to arbitrally decide which studies to accept and which do not. It would end in mayhem. In Belarus, we often see this, and it usually ends that we have to prove that the globe is round not flat.

If TIE must be controlled in ABEL/RABE, it should be ingrained in regulatory documents. Full stop.

If somebody decided to risk and won (passing bioequivalence on ABE terms), these studies should be accepted. Otherwise, you would reject valid studies and would dictate how sponsors should spend their own money and how different countries have to vet BE trials. I am very skeptical that this decision tree can be outlawed (it is diffuclt to prosecute for things that did not happen), but legal experts may have other opinions.

What is about ABEL/RABE trials when the CV is around 30% or uncertain but not small? Should we pump up the sample size in this case (I guess a majority of cases) to the level close to ABE trials which basically invalidates the whole concept of ABEL/RABE?

Finally, I am not a statistician but wether your approach itself also might inflate TIE when we have to calculate RR (population parameter) and then CI which we compare with a standard or widened bioequivalence interval. We do two calculations in which alpha levels are involved.

Best regards

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