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A web application for evaluating Phase I methods using a non-parametric optimal benchmark.

Nolan A Wages1, Nikole Varhegyi1

  • 1Division of Translational Research & Applied Statistics, Department of Public Health Sciences, The University of Virginia, Charlottesville, VA, USA.

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Summary
This summary is machine-generated.

This study introduces a user-friendly R shiny web application to evaluate Phase I dose-finding designs. The tool provides a benchmark for assessing maximum tolerated dose selection accuracy in simulations.

Keywords:
Dose-findingPhase Ibenchmarkoptimal designshinysoftware

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Area of Science:

  • Pharmacology
  • Biostatistics
  • Clinical Trial Design

Background:

  • Phase I clinical trials aim to find the maximum tolerated dose (MTD) using dose-finding designs.
  • Simulation studies are crucial for evaluating these designs, but often lack a performance benchmark.
  • Assessing the upper bound of MTD selection accuracy is essential for realistic simulation evaluations.

Purpose of the Study:

  • To provide researchers with accessible software for evaluating Phase I dose-finding methods.
  • To introduce a benchmark for assessing the operating characteristics of MTD selection.
  • To facilitate the use of the non-parametric optimal benchmark in dose-finding simulations.

Main Methods:

  • Development of an R shiny web application to simulate the non-parametric optimal benchmark.
  • The benchmark serves as a theoretical upper limit for MTD identification accuracy.
  • Utilizes a binary toxicity endpoint for simulation.

Main Results:

  • The web application provides quick simulation results for the benchmark.
  • No programming knowledge is required to use the application.
  • Accessible for free on any internet-connected device.

Conclusions:

  • The application calculates the percentage of correct MTD selection and an accuracy index.
  • These metrics are standard operating characteristics for evaluating dose-finding designs.
  • Aims to enhance the evaluation of dose-finding simulations using the benchmark.