ATSS_Design_Stage2: Adaptive Threshold and Sample Size Simon Design Two Stages

In UnplanSimon: Methods for Managing Enrollment Deviation in Simon's Two-Stage Design

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

UnplanSimon documentation built on Oct. 25, 2024, 5:08 p.m.