ATSS_Design_Stage2 {UnplanSimon} | R Documentation |
Adaptive Threshold and Sample Size Simon Design Two Stages
Description
ATSS_Design_Stage2( ) provides an Adaptive Threshold and Sample Size Simon Design (ATSS Simon) method for Simon's two stage design in oncology trials when the realized sample sizes in the second stage is different from the planned sample sizes in the second stage from interim analysis new design. Further adjustment of the threshold at the second stage is needed. So, we update again the second stage threshold r* to satisfy the type I error rate given the interim analysis design first stage threshold r1* and actual two stages sample sizes (n1*, n**).
Usage
ATSS_Design_Stage2(p0, p1, r1_star, n1_star, n_double_star, alpha)
Arguments
p0 |
Unacceptable efficacy rate |
p1 |
Desirable efficacy rate |
r1_star |
Interim analysis design threshold in stage 1 |
n1_star |
The actual number of patients in stage 1 |
n_double_star |
The actual total number of patients in stages 1 and 2 |
alpha |
Original Type-I error rate |
Value
a data frame includes the Adaptive Threshold and Sample Size Simon Design interim analysis design adjusted first stage threshold r1*, Adaptive Threshold and Sample Simon Design stage 2 new design adjusted second stage threshold r*, actual number of patients in the first stage n1*, actual total number of patients in stages 1 and 2 n**, attained Type-I error and Power, Average sample size under null hypothesis EN(p0) and Probability of early termination under null hypothesis PET(p0).
References
Yunhe Liu, & Haitao Pan. (2024). Clinical Trial Design Methods for Managing Under- and Over-Enrollment in Simon's Two-Stage Design, Submitted.
Examples
# Adaptive Threshold and Sample Size Simon Design two stages analysis case 1
ATSS_Design_Stage2(0.05, 0.20, 1, 20, 33, 0.10)
# r1* r* n1* n** Type I Power EN(p0) PET(p0)
# ATSS_Design_Stage2 1 3 20 33 0.07 0.888 23.434 0.736
# Adaptive Threshold and Sample Size Simon Design two stages analysis case 2
ATSS_Design_Stage2(0.10, 0.30, 2, 18, 24, 0.10)
# r1* r* n1* n** Type I Power EN(p0) PET(p0)
#ATSS_Design_Stage2 2 4 18 24 0.08 0.876 19.597 0.734