Triggering Condition by Number of Randomized Patients

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)

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.

Value

an object of class `Condition`

Examples


## ensure sufficient sample size of whole trial
enrollment(n = 100)
#> Number of randomized patients >=  100

## ensure sufficient sample size in sub-group of interest
enrollment(n = 100, biomarker1 == 'positive' & biomarker2 == 'high')
#> Number of randomized patients >=  100 with conditions: ~biomarker1 == "positive" & biomarker2 == "high"

## ensure sufficient sample size in high dose + placebo
enrollment(n = 1000, arms = c('high dose', 'placebo'))
#> Number of randomized patients >=  1000 in arms < high dose, placebo > 
#> 

## ensure sufficient treatment duration
enrollment(n = 500, min_treatment_duration = 2)
#> Number of randomized patients >=  500 and all enrolled patients have been treated for < 2 > (unit time) 
#>