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Ok, say I give all this to you? Are we saying this type of Bayesian sequential design is good only for prelim studies? If so why is that?
The ph3 NRG-GI 006 also led by the same PI Dr. Steven Lin is reverting back to "old school" stats. The primary endpoints are now good ol' K-M OS and CTCAE 5.0 (not TTB) toxicity!
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What is your guess on what is going on? Like I said, I think the Bayesian design may bring up too many questions for standard of care, but also allows less numbers for pre-ph3 data (needed only 107 patients). Sample size reqs for GI006 is double at 300.
Would love to hear your opinion on this change in ph3.
tbe difference is you can do whatever the f you want if the trial is MDACC
you cannot do whatever you want once it’s cooperative group