PE outside {0.80, 1.25} not possible [Two-Stage / GS Designs]
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.
!!
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
!!
Complete thread:
- Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 11:20 [Two-Stage / GS Designs]
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
- Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
- Extreme test case Helmut 2023-12-24 13:01
- Extreme GMR Naksh 2023-12-25 04:16
- PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
- PE outside {0.80, 1.25} not possibleNaksh 2023-12-25 11:42
- Forget rss() Helmut 2023-12-25 13:15
- Forget rss() Naksh 2023-12-26 04:49
- TSD useful at all? Helmut 2023-12-26 12:50
- Forget rss() Naksh 2023-12-26 04:49
- Forget rss() Helmut 2023-12-25 13:15
- PE outside {0.80, 1.25} not possibleNaksh 2023-12-25 11:42
- PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
- Extreme GMR Naksh 2023-12-25 04:16
- Extreme test case Helmut 2023-12-24 13:01
- Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10