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Back to the forum  2018-06-21 19:47 CEST (UTC+2h)
Ben
Regular

2017-03-13 18:55

Posting: # 17150
Views: 971
 

 Bayesian BE Assessment [Study As­sess­ment]

Dear All,

In times where Bayesian techniques come more often I was wondering about BE trials and therefore my question: Has anyone of you evaluated a BE trial using Bayesian techniques? I guess in a confirmatory setting the answer of our regulators is clear: not acceptable. Or not? Ok, maybe as a secondary analysis. What was the feedback from the agency? What kind of prior did you use? (interesting would of course be a case which is not non-informative like in [1, Section 5.9])

Experiences or ideas are much appreciated.

Thanks,
Ben.

[1] Patterson, Jones. Bioequivalence and Statistics in Clinical Pharmacology. Chapman & Hall/CRC, Boca Raton 2006.
DavidManteigas
Regular

Portugal,
2017-03-14 11:45

@ Ben
Posting: # 17153
Views: 780
 

 Bayesian BE Assessment

Hi Ben,

If current frequentist methods for studies where bayesian analysis may fit (two-stage) are full of controversies in the regulators point of view, I can't even imagine if you introduce bayesian methods to them in those cases :-D

I'm not a frequentist phanatic. I believe both approaches are valid depending on the problems and study designs under consideration. Regarding bioequivalence however, I don't see how bayesian inference may add any value. The same is not true for therapeutic equivalence studies (biosimilars), where I believe bayesian methods would be very advantageous since you already "have" prior "information" regarding treatments.

Regards,
David
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