drugdevelopR (version 1.0.2)

PsProg_tte: 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)

Value

The function PsProg_tte() returns the probability of a successful program

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)

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)