Probability of Success in BE studies [Design Issues]

posted by Achievwin – US, 2024-05-03 15:43 (182 d 18:58 ago) – Posting: # 23977
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Recently I was asked to give Probability of success for a proposed BE study, My thinking is Target study power (usually 80%) is POS with additional correction factor due to the variability during study conduct applied to this target power, is my understanding correct?

Challenge is that do you substract or a multiply the variability factor?

e.g. POS = Target Power (90) - 30 (CV)= 60 0r 90X(1-0.30)=63%

Achievwin

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