sim.one.trial: Simulate one BF-BOIN trial

In bfboin: Operating Characteristics for the Bayesian Optimal Interval Design with Back Filling

Simulate one BF-BOIN trial

Description

Simulate one BF-BOIN trial

Usage

sim.one.trial(
  trial.id = 1,
  target = 0.25,
  p.true = c(0.1, 0.3, 0.5),
  ncohort = 10,
  cohortsize = 3,
  n.earlystop = 100,
  startdose = 1,
  titration = FALSE,
  p.saf = 0.6 * target,
  p.tox = 1.4 * target,
  cutoff.eli = 0.95,
  extrasafe = FALSE,
  offset = 0.05,
  boundMTD = FALSE,
  n.cap = 12,
  end.backfill = TRUE,
  n.per.month = 3,
  dlt.window = 1,
  p.response.true = c(1, 1, 1),
  three.plus.three = FALSE,
  accrual = "uniform",
  backfill.assign = "highest"
)

Arguments

trial.id	an ID for the trial
target	the target DLT rate
p.true	a vector containing the true toxicity probabilities of the investigational dose levels.
ncohort	the total number of cohorts
cohortsize	the cohort size
n.earlystop	the early stopping parameter. If the number of patients treated at the current dose reaches n.earlystop, stop the trial and select the MTD based on the observed data. The default value n.earlystop=100 essentially turns off this type of early stopping.
startdose	the starting dose level for the trial
titration	set titration=TRUE to perform dose escalation with cohort size = 1 to accelerate dose escalation at the begining of the trial.
p.saf	the highest toxicity probability that is deemed subtherapeutic (i.e. below the MTD) such that dose escalation should be undertaken. The default value is p.saf=0.6*target.
p.tox	the lowest toxicity probability that is deemed overly toxic such that deescalation is required. The default value is p.tox=1.4*target).
cutoff.eli	the cutoff to eliminate an overly toxic dose for safety. We recommend the default value of (cutoff.eli=0.95) for general use.
extrasafe	set extrasafe=TRUE to impose a more stringent stopping rule
offset	a small positive number (between 0 and 0.5) to control how strict the stopping rule is when extrasafe=TRUE. A larger value leads to a more strict stopping rule. The default value offset=0.05 generally works well.
boundMTD	set boundMTD=TRUE to impose the condition: the isotonic estimate of toxicity probability for the selected MTD must be less than de-escalation boundary.
n.cap	permanently close a dose for backfilling if the number of patients assigned to the dose reaches n.cap
end.backfill	when the dose escalation ends, the backfilling by definition also ends. Default is TRUE.
n.per.month	patient accrual rate per month
dlt.window	DLT assessment window (months)
p.response.true	a vector containing the true response probabilities of the investigational dose levels
three.plus.three	modify the decision from de-escalation to stay when observing 1 DLT out of 3 patients
accrual	"uniform" or "poisson", according to whether accrual distribution is uniform (consistent with Shiny App) or a Poisson process (consistent with publication)
backfill.assign	How to assign backfill dose given the open backfill doses. Options are "highest" (default), "lowest", or "random".

Value

A data frame with the number of patients and number of DLTs at each dose level

bfboin documentation built on Aug. 8, 2025, 6:24 p.m.