# The following code derives the group sequential design using the method
# of Lachin and Foulkes
x <- gsSurv(
k = 3, # 3 analyses
test.type = 4, # Non-binding futility bound 1 (no futility bound) and 4 are allowable
alpha = .025, # 1-sided Type I error
beta = .1, # Type II error (1 - power)
timing = c(0.45, 0.7), # Proportion of final planned events at interims
sfu = sfHSD, # Efficacy spending function
sfupar = -4, # Parameter for efficacy spending function
sfl = sfLDOF, # Futility spending function; not needed for test.type = 1
sflpar = 0, # Parameter for futility spending function
lambdaC = .001, # Exponential failure rate
hr = 0.3, # Assumed proportional hazard ratio (1 - vaccine efficacy = 1 - VE)
hr0 = 0.7, # Null hypothesis VE
eta = 5e-04, # Exponential dropout rate
gamma = 10, # Piecewise exponential enrollment rates
R = 16, # Time period durations for enrollment rates in gamma
T = 24, # Planned trial duration
minfup = 8, # Planned minimum follow-up
ratio = 3 # Randomization ratio (experimental:control)
)
# Convert bounds to exact binomial bounds
toInteger(x, ratio = 3)
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