EU: ABEL TIE?? [Two-Stage / GS Designs]

posted by mittyri – Russia, 2019-10-19 23:24 (463 d 14:13 ago) – Posting: # 20707
Views: 2,206

Hi Helmut,

» an update: Yesterday at the 4th Biosimilars Forum a participant asked whether simulation-based methods (control of the type I error in a sufficiently high number of simulations, i.e., 1 mio in each cell of a narrow grid of n1/CV combinations) are acceptable. Andreas Brandt (BfArM and observer at the BSWP) answered “No.”

sad story
BTW: in your lecture you suggested to adjust the CIs for ABEL due to TIE inflation. Is that also dead?
Does it mean that you cannot prove anything using sims??

Kind regards,

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