PsProg_tte: Probability of a successful program for multiarm programs...

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

Probability of a successful program for multiarm programs with time-to-event outcomes

Description

Given we get the "go"-decision in phase II, this functions now calculates the probability that the results of the confirmatory trial (phase III) are significant, i.e. we have a statistically relevant positive effect of the treatment.

Usage

PsProg_tte(HRgo, n2, alpha, beta, ec, hr1, hr2, step1, step2, strategy, case)

Arguments

HRgo	threshold value for the go/no-go decision rule
n2	total sample size for phase II; must be divisible by three
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
step1	lower boundary for effect size
step2	upper boundary for effect size
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 PsProg_tte() returns the probability of a successful program

Examples

res <- PsProg_tte(HRgo = 0.8 ,n2 = 50 ,alpha = 0.05, beta = 0.1,
                            ec = 0.6, hr1 = 0.7, hr2 = 0.8, step1 = 1, step2 = 0.95,
                            strategy = 2, case = 21)

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