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Ben ★ Germany, 2017-03-13 19:55 (3386 d 22:27 ago) Posting: # 17150 Views: 4,657 |
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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. |
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DavidManteigas ★ Portugal, 2017-03-14 12:45 (3386 d 05:37 ago) @ Ben Posting: # 17153 Views: 3,663 |
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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  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 |
Ing. Helmut Schütz