--- title: "Getting started with survSampleSize" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{Getting started with survSampleSize} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} --- ```{r, include = FALSE} knitr::opts_chunk$set( collapse = TRUE, comment = "#>", eval = FALSE ) ``` ## Overview `survSampleSize` provides an interactive Shiny application for sample size and power calculation in clinical trials with a survival (time-to-event) endpoint, under general design conditions. Two complementary methods are available: - The **Lu (2021)** weighted log-rank method (via the `lrstat` package), which supports non-proportional hazards, delayed treatment effects, unequal allocation, dropout, non-inferiority testing, and Fleming-Harrington weighted log-rank statistics. - The classic **Freedman (1982)** method (via the `powerSurvEpi` package) for the proportional-hazards setting. ## Launching the application The package exposes a single user-facing function, `run_app()`, which launches the Shiny application in your default browser: ```{r} library(survSampleSize) run_app() ``` The interactive app relies on several packages declared in `Suggests`. If any are missing, `run_app()` reports which ones to install. You can install all of them up front with: ```{r} install.packages(c( "lrstat", "powerSurvEpi", "DT", "ggplot2", "bslib", "plotly" )) ``` ## Workflow Inside the app, the typical workflow is: 1. **Choose method and direction.** Select either the Lu (2021) or Freedman (1982) method, and whether to solve for the sample size *N* given a target power, or to solve for the power given a fixed *N*. 2. **Statistical design parameters.** Set the significance level (alpha), target power, one- vs. two-sided test, allocation ratio, and -- for the Lu method -- an optional non-inferiority margin. 3. **Time parameters (months).** Set the accrual duration and the follow-up time after accrual ends. The Freedman method instead uses a single total study duration. 4. **Survival and effect parameters.** Set the control-arm median survival, the target hazard ratio, and -- for the Lu method -- the delayed-effect (DTE) time, the annual dropout rate, the accrual rate, and the Fleming-Harrington weighting. 5. **Calculate.** The results panel reports the total sample size, expected number of events, study duration, and/or estimated power. Additional tabs show the theoretical survival curves, a calendar-time event-prediction timeline, and a side-by-side comparison of the two methods. ## References - Freedman, L. S. (1982). Tables of the number of patients required in clinical trials using the log-rank test. *Statistics in Medicine*, 1(2), 121-129. \doi{10.1002/sim.4780010204} - Lu, K. (2021). Sample size calculation for logrank test and prediction of number of events over time. *Pharmaceutical Statistics*, 20(2), 229-244. \doi{10.1002/pst.2069}