| HR.APPLE.plus {DelayedEffect.Design} | R Documentation |
APPLE+ hazard ratio computation
Description
Perform the post-delay hazard ratio calculation given power and sample size using the close-form APPLE+ method based on the generalized piecewise weighted log-rank test when the treatment time-lag effect is present and the lag duration varies heterogeneously from individual to individual or from study to study, within a certain domain and following a specific pattern.
Usage
HR.APPLE.plus(lambda1, tl, tu, N, tao, A, beta, ap=0.5, alpha=0.05)
Arguments
lambda1 |
Baseline hazard |
tl |
Lower bound of delayed duration domain |
tu |
Upper bound of delayed duration domain |
N |
Sample size |
tao |
Total study duration |
A |
Total enrollment duration |
beta |
Type II error rate; Power=1-beta |
ap |
Experimental-control allocation ratio. The default is 0.5. |
alpha |
Type I error rate (two-sided). The default is 0.05. |
Details
APPLE+ is an acronym for:
Analytic Power calculation method based on generalized Piecewise weighted Log-rank tEst
with random treatment time-lag effect.
See the reference for details of this method.
Value
The hazard ratio
Author(s)
Zhenzhen Xu <Zhenzhen.Xu@fda.hhs.gov>, Boguang Zhen<Boguang.Zhen@fda.hhs.gov>, Yongsoek Park <yongpark@pitt.edu> and Bin Zhu <bin.zhu@nih.gov>
References
Xu, Z., Park, Y., Zhen, B. & Zhu, B. (2017). Achieving optimal power of logrank test with random treatment time-lag effect. Biometrika. Under review.
Xu, Z., Zhen, B., Park, Y., & Zhu, B. (2017). Designing therapeutic cancer vaccine trials with delayed treatment effect. Statistics in medicine, 36(4), 592-605.
See Also
Examples
lambda1 <- 0.001982
tl <- 30
tu <- 30*11
N <- 200
tao <- 365*3
A <- 365
beta <- 0.2
HR.APPLE.plus(lambda1, tl, tu, N, tao, A, beta)