Package 'titeIR'

Title: Isotonic Designs for Phase 1 Trials with Late-Onset Toxicities
Description: Functions to design phase 1 trials using an isotonic regression based design incorporating time-to-event information. Simulation and design functions are available, which incorporate information about followup and DLTs, and apply isotonic regression to devise estimates of DLT probability.
Authors: Lee McDaniel [aut, cre]
Maintainer: Lee McDaniel <[email protected]>
License: GPL-3
Version: 0.1.0
Built: 2025-02-22 03:54:12 UTC
Source: https://github.com/cran/titeIR

Help Index


Dose assignment for TITE-IR designs

Description

Calculate the next dose assignment for a TITE-IR design.

Usage

isotitedose(followup, DLT, assignment, obswin, doses, target = 1/3,
  safety = 0.05)

Arguments

followup

A vector of followup times

DLT

A vector of DLT results. FALSE or 0 is interpreted as no observed DLT and TRUE or 1 is interpreted as observed DLT.

assignment

a vector of dose assignments. Doses should be labeled in consecutive integers from 1 to number of dose levels.

obswin

The observation window with respect to which the MTD is defined.

doses

An integer providing the number of doses.

target

Target DLT rate

safety

The safety factor to prevent overly aggressive escalation

Value

an integer specifying the recommended dose level

See Also

isotitesim for simulations

Examples

isotitedose(followup = c(6, 5, 4, 3, 2, 1), DLT = c(0, 0, 0, 0, 0, 0),
 assignment = c(1, 1, 1, 2, 2, 2), obswin = 6, doses = 6)

Simulate TITE-IR designs

Description

Simulates trials based on the TITE-IR design.

Usage

isotitesim(PI, target, n, nsim, obswin = 1, rate = 1, safety = 0.05,
  accrual = "poisson", restrict = TRUE)

Arguments

PI

A vector of true toxicity probabilities at each dose

target

Target DLT rate

n

Sample size of the trial

nsim

Number of trial replicates

obswin

The observation window with respect to which the MTD is defined

rate

Patient arrival rate: expected number of arrivals per observation window

safety

The safety factor to prevent overly aggressive escalation

accrual

Specify the accrual distribution. Can be either "poisson" or "fixed". Partial strings are also acceptable.

restrict

If TRUE, do not allow escalation immediately after a toxic outcome (require coherent escalation)

Value

Object of type isotite which provides results from TITE-IR simulations

See Also

isotitedose for dose recommendation

Examples

isotitesim(PI = c(0.05, 0.10, 0.20, 0.30, 0.50, 0.70),
 target = 1/3, n = 24, nsim = 10, obswin = 6, rate = 12)