The goal of RMSTdesign is to make it easy to design clinical trials with the difference in restricted mean survival time as the primary endpoint. This includes calcuating asymptotic power or sample size under user-specified design parameters and performing simulations to determine the operating characteristics of the test of restricted mean survival time.
Installation
You can install RMSTdesign from GitHub with:
# install.packages("devtools")
devtools::install_github("anneae/RMSTdesign")Documentation
Documentation and vignettes are available here.
Example
In this basic example, we specify that the control group is expected to have a median survival of 3 years, the treatment group is expected to have a median survival of 4 years, and we plan to accrue patients over one year and follow them until the last patient has 3 years of followup. Also, we select \(\tau\) = 3 years as a clinically meaningful restriction time. The code below determines the required sample size for a trial with 80% power.
library(RMSTdesign)
con<-survdef(times = 3, surv = 0.5)
trt<-survdef(times = 4, surv = 0.5)
RMSTpow(con, trt, k1 = 1, k2 = 3, tau = 3, power = 0.8)
#> $n
#> [1] 1024
#>
#> $powerRMST
#> [1] 0.8004313
#>
#> $powerRMSTToverC
#> [1] 0.8004313
#>
#> $powerRMSTCoverT
#> [1] NA
#>
#> $powerLRToverC
#> [1] 0.9033999
#>
#> $powerLRCoverT
#> [1] NA
#>
#> $powerLRtauToverC
#> [1] 0.8707378
#>
#> $powerLRtauCoverT
#> [1] NA
#>
#> $pKME
#> [1] 1