ss_normal: 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 normally distributed 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_normal(alpha, beta, y, l)

Arguments

alpha	significance level
beta	1-'beta' power for calculation of sample size for phase III
y	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_normal() returns the total sample size for phase III trial with l treatments and equal allocation ratio

Examples

res <- ss_normal(alpha = 0.05, beta = 0.1, y = 0.5, l = 1)

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