TrialSimulator (version 1.7.0)

enrollment: Triggering Condition by Number of Randomized Patients

Description

Define a condition to trigger trial milestone by the number of randomized patients. The milestone will be triggered when a trial has enrolled at least the specified number of patients. It can be used combined with conditions specified by calendarTime and eventNumber.

Refer to the vignette to learn how to define milestones when performing simulation using TrialSimulator.

Usage

enrollment(n, ..., arms = NULL, min_treatment_duration = 0)

Value

an object of class `Condition`

Arguments

n

integer. Number of randomized patients.

...

subset conditions compatible with dplyr::filter. Number of randomized patients will be counted on subset of trial data only.

arms

vector of character. Name of arms on which the number of patients is counted. If NULL, use all arms that are not yet removed from the trial by the time of calculation.

min_treatment_duration

numeric. Zero or positive value. minimum treatment duration of enrolled patients. Default is 0, i.e., looking for triggering time based on number of enrolled patients in population specified by ... and arms. If positive, it means that milestone is triggered when a specific number of enrolled patients have received treatment for at least min_treatment_duration duration. It is users' responsibility to assure that the unit of min_treatment_duration are consistent with readout of non-tte endpoints, dropout time, and trial duration.

Examples

## ensure sufficient sample size of whole trial
enrollment(n = 100)

## ensure sufficient sample size in sub-group of interest
enrollment(n = 100, biomarker1 == 'positive' & biomarker2 == 'high')

## ensure sufficient sample size in high dose + placebo
enrollment(n = 1000, arms = c('high dose', 'placebo'))

## ensure sufficient treatment duration
enrollment(n = 500, min_treatment_duration = 2)