Ess_tte: 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 time-to-event 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() function

Usage

Ess_tte(HRgo, n2, alpha, beta, ec, hr1, hr2, strategy, case)

Arguments

HRgo	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
ec	control arm event rate for phase II and III
hr1	assumed true treatment effect on HR scale for treatment 1
hr2	assumed true treatment effect on HR scale for treatment 2
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_tte() returns the expected sample size for phase III when going to phase III

Examples

res <- Ess_tte(HRgo = 0.8 ,n2 = 50 ,alpha = 0.05, beta = 0.1,
                            ec = 0.6, hr1 = 0.7, hr2 = 0.8, strategy = 2, case = 21)

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