simtrials.tite {stoppingrule}R Documentation

Simulate trials with safety monitoring by the TITE method

Description

Internal workhorse function used to simulate trials with safety monitoring by the TITE method. The provided stopping rule is used for monitoring of MC simulated trials. For each trial, a random sample is generated from either a Weibull distribution with shape parameter s or power distribution with power parameter to attain a toxicity rate of p. Enrollment times are simulated over an accrual period of duration A under a uniform (0,A) distribution.

Usage

simtrials.tite(rule, p, tau, MC, A, family, s)

Arguments

rule

A rule.tite object with the safety stopping rule for evaluation

p

Vector of cumulative incidence probabilities at time tau for all causes (length 1 for survival, 2 for competing risks)

tau

Length of observation period

MC

Number of Monte Carlo replicated datasets to simulate

A

Length of accrual period

family

Event time distribution, choices including Weibull distribution ('weibull') and power family ('power')

s

Shape parameter for Weibull distribution or power parameter for power family

Value

A matrix with MC rows and 14 columns, one row per simulated trial. Columns include the stopping rule type and design parameters, the numbers of events and enrolled patients, the total follow-up time in the cohort, the calendar time when the study ends, the reject/no reject decision, and the last stage of monitoring reached when the study ends.

Examples

## Not run: 
set.seed(2025)

## End(Not run)

[Package stoppingrule version 0.6 Index]