ATSS_Design_Stage1: Adaptive Threshold and Sample Size Simon Design Interim...

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

Adaptive Threshold and Sample Size Simon Design Interim Analysis

Description

ATSS_Design_Stage1( ) 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 first stage is different from the planned sample sizes in the first stage. When under-enrollment or over-enrollment occurs at the first stage, we identify the design parameters (r1*, r*, n*) based on the actual sample size n1* ar the first stage to satisfy the type I error rate and power. In addition, the ATSS Simon design also satisfies the other criteria as in the originally planned design, such as minimizing the average sample size under the null hypothesis H0.

Usage

ATSS_Design_Stage1(p0, p1, n1_star, alpha, beta)

Arguments

p0	Unacceptable efficacy rate
p1	Desirable efficacy rate
n1_star	The actual number of patients in stage 1
alpha	Original Type-I error rate
beta	Original Type-II error rate

Value

a data frame includes the Adaptive Threshold and Sample Simon Design interim analysis' adjusted first stage threshold r1*, second stage threshold r*, actual number of patients in the first stage n1*, new design planned two stages' patients n*, attained Type-I error rate 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 interim analysis case 1
ATSS_Design_Stage1(0.05, 0.20, 20, 0.10, 0.10)
#                    r1* r* n1* n* Type I Power EN(p0) PET(p0)
# ATSS_Design_Stage1   1  3  20 35   0.08 0.901 23.962   0.736

# Adaptive Threshold and Sample Size Simon Design interim analysis case 2
ATSS_Design_Stage1(0.10, 0.30, 18, 0.10, 0.10)
#                    r1* r* n1* n* Type I Power EN(p0) PET(p0)
# ATSS_Design_Stage1   2  4  18 26  0.099 0.904  20.13   0.734

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