Ess_normal: Expected sample size for phase III for multiarm programs with...

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

Expected sample size for phase III for multiarm programs with normally distributed outcomes

Description

Given phase II results are promising enough to get the "go"-decision to go to phase III this function now calculates the expected sample size for phase III given the cases and strategies listed below. The results of this function are necessary for calculating the utility of the program, which is then in a further step maximized by the optimal_multiarm_normal() function

Usage

Ess_normal(kappa, n2, alpha, beta, Delta1, Delta2, strategy, case)

Arguments

kappa	threshold value for the go/no-go decision rule
n2	total sample size for phase II; must be even number
alpha	significance level
beta	1-beta power for calculation of sample size for phase III
Delta1	assumed true treatment effect for standardized difference in means
Delta2	assumed true treatment effect for standardized difference in means
strategy	choose Strategy: 1 ("only best promising"), 2 ("all promising") or 3 (both)
case	different cases: 1 ("nogo"), 21 (treatment 1 is promising, treatment 2 is not), 22 (treatment 2 is promising, treatment 1 is not), 31 (both treatments are promising, treatment 1 is better), 32 (both treatments are promising, treatment 2 is better)

Value

The function Ess_normal() returns the expected sample size for phase III when going to phase III when outcomes are normally distributed and we consider multiarm programs, i.e. several phase III trials with different doses or different treatments are performed

Examples

res <- Ess_normal(kappa = 0.1 ,n2 = 50 ,alpha = 0.05, beta = 0.1,
                            Delta1 = 0.375, Delta2 = 0.625, strategy = 3, case = 31)

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