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.
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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
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