SSRMST-package: Sample Size Calculation using Restricted Mean Survival Time
In SSRMST: Sample Size Calculation using Restricted Mean Survival Time

Description Details Author(s) References See Also Examples

The difference in restricted mean survival time (RMST), a clinically interpretable model-free measure, can be one of the alternatives to the hazard ratio. The package calculates the study sample size and power in designing clinical trials using the difference in RMST. Two types of one-sided tests, non-inferiority and superiority tests, are prepared.

Please check the vignette for details: browseVignettes(package = "SSRMST")

Miki Horiguchi, Hajime Uno

Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei LJ. Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. Journal of clinical Oncology 2014, 32, 2380-2385.

Uno H, Wittes J, Fu H, Solomon SD, Claggett B, Tian L, Cai T, Pfeffer MA, Evans SR, Wei LJ. Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in non-inferiority Studies. Annals of Internal Medicine 2015, 163, 127-134.

survival survRM2

#---Example data

ac_rate   = 15
ac_period = 35
tot_time  = 510
tau       = 500
scale0    = 8500
scale1    = 8500
margin    = 18

a = ssrmst(ac_rate=ac_rate, ac_period=ac_period, tot_time=tot_time,
           tau=tau, scale0=scale0, scale1=scale1, margin=margin, ntest=20)
print(a)

Non-inferiority test 

                          Total arm0 arm1
Sample size                 524  262  262
Expected number of events    29   15   14

Power (separate) 
             0.9 
Power (pooled) 
           0.9