--- title: "Detectable Event Rate for Safety Signal Detection: Using `power_single_rate`" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{Detectable Event Rate for Safety Signal Detection} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} --- ## Introduction One important question in drug safety monitoring or rare event studies is: > "**Given a specific sample size and the desired statistical power, what is the smallest event rate (proportion) that can be reliably detected (i.e., at least one event expected with a set probability)?**" The function `power_single_rate()` addresses this by calculating the minimum true underlying proportion of an event needed, so that, with a specified sample size, there is a specified power to observe at least one event. This is typically used in clinical trial planning or post-marketing safety surveillance, where the event (such as a serious adverse reaction) is rare, but assuring a high probability to observe at least one event if the true rate is sufficiently high is crucial for safety oversight. ## Function The function signature is: ```r power_single_rate(subjects, power) ``` - `subjects`: Integer or vector. Sample size(s). - `power`: Numeric or vector. Desired power(s), between 0 and 1. The function returns a matrix (class `power_single_rate`) with columns: - `n`: sample size, - `power`: statistical power, - `proportion`: minimum detectable event rate. A formatted print and summary are provided for nice displays. ## Examples ### Example 1: 100 Subjects, Power 0.95 Suppose you want to know the lowest event rate that would provide a 95% chance of observing at least one event among 100 subjects. ```{r example1} library(ssutil) power_single_rate(100, 0.95) ``` ### Example 2: 30 Subjects, Power 0.95, 0.90, and 0.8 Suppose your sample size is 30, and you want to know what true event rate you can potentially detect (at least one event) with powers of 80%, 90%, and 95%. ```{r example2} power_single_rate(30, c(0.95, 0.90, 0.8)) ```