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Summary
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We developed user-friendly R and Shiny software for implementing advanced calibration-free odds (CFO) type designs in clinical trials. These tools enhance dose-finding accuracy and efficiency by integrating randomization and various CFO design variants.

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • Calibration-free odds (CFO)-type designs are the current standard for robust and model-free dose-finding in clinical trials.
  • A significant barrier to the widespread adoption of CFO-type designs is the lack of accessible implementation tools.

Purpose of the Study:

  • To develop user-friendly R package and Shiny web-based software for the practical implementation of CFO-type designs.
  • To incorporate randomization into the CFO framework, creating the randomized CFO (rCFO) design.

Main Methods:

  • Developed the R package "CFO" and an interactive R Shiny web application named "CFO suite".
  • Integrated an exploration-exploitation mechanism via randomization to introduce the rCFO design.
  • Incorporated various CFO design variants including 2dCFO, aCFO, TITE-CFO, fCFO, TITE-aCFO, and fractional-aCFO.

Main Results:

  • The CFO package and CFO suite offer a comprehensive suite of tools for various clinical trial settings.
  • Functions are provided for dose determination, maximum tolerated dose selection, and performance evaluation through simulations.
  • Outputs include both textual and graphical representations of simulation and trial results.

Conclusions:

  • The CFO package and CFO suite provide flexible and comprehensive tools for implementing CFO-type designs in Phase I clinical trials.
  • This work integrates existing CFO-type designs, enabling novel trial designs with improved performance.
  • The user-friendly software promotes the adoption of advanced statistical methods and strengthens biostatistician-clinician collaboration for enhanced trial efficiency and accuracy.