ss_tte: Total sample size for phase III trial with l treatments and...

In Sterniii3/drugdevelopR: Utility-Based Optimal Phase II/III Drug Development Planning

Total sample size for phase III trial with l treatments and equal allocation ratio for time-to-event outcomes

Description

Depending on the results of phase II and our strategy ,i.e. whether we proceed only with the best promising treatment (l = 1) or with all promising treatments (l = 2), this program calculates the number of participants in phase III.

l=1: according to Schoenfeld to guarantee power for the log rank test to detect treatment effect of phase II;

l=2: according to Dunnett to guarantee y any-pair power (Horn & Vollandt)

Usage

ss_tte(alpha, beta, ec, ek, y, l)

Arguments

alpha	significance level
beta	1-beta power for calculation of sample size for phase III
ec	control arm event rate for phase II and III
ek	event rate of arm k (either arm 1 or arm 2)
y	hat_theta_2; estimator in phase II
l	number of treatments in phase III: l=1: according to Schoenfeld to guarantee power for the log rank test to detect treatment effect of phase II; l=2: according to Dunnett to guarantee y any-pair power (Horn & Vollandt)

Value

the function ss_tte() returns the total sample size for phase III trial with l treatments and equal allocation ratio

Examples

res <- ss_tte(alpha = 0.05, beta = 0.1, ec = 0.6, ek = 0.8, y = 0.5, l=1)

Sterniii3/drugdevelopR documentation built on Jan. 26, 2024, 6:17 a.m.