PE outside {0.80, 1.25} not possible [Two-Stage / GS Designs]

posted by Naksh – India, 2023-12-25 12:42 (210 d 15:44 ago) – Posting: # 23807
Views: 2,423

Namaste Helmut !

Thanks for the reply and I agree that PE outside is not possible but it has been observed in pilot studies of mesalamine where many BLQs are observed in a subject which skewed the T/R to the extreme.

95% is a very bold to assume in HVD. but should actual T/R ratio for re-estimation of sample size? somehow it should be according to potvin method B?

This wonders me with T/R ratio of 85% as well.

power.RSABE(alpha = 0.0294, theta0 = 0.85, CV = 0.6978, n = 24, design = "2x2x4")
[1] 0.6369
rss(n = 24, r = 2, S_WR = 0.630, params = list(sig_level=0.0294))
$rss
[1] 21

rss(n = 24, r = 2, S_WR = 0.630, params = list(sig_level=0.0294, GMR=0.85))
$rss
[1] 100


!!

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