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Isotonic designs for phase I trials in partially ordered groups.

Mark Conaway1,2

  • 11 University of Virginia Health System, Charlottesville, VA, USA.

Clinical Trials (London, England)
|August 5, 2017
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Summary

This study introduces a new computational method for dose-finding trials, applicable to cytotoxic agents in patient groups with completely or partially ordered toxicity risks. The method offers a feasible solution for designing such trials.

Keywords:
Partial orderdose-findingmultiple risk groups

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacology

Background:

  • Dose-finding trials often stratify patients into risk groups.
  • These groups can be completely ordered or partially ordered by toxicity risk.
  • Existing methods may not adequately address partially ordered groups.

Purpose of the Study:

  • To introduce a novel method for designing dose-finding trials.
  • The method is applicable to cytotoxic agents in completely or partially ordered patient risk groups.
  • To provide a computationally feasible approach for complex trial designs.

Main Methods:

  • Combines existing mathematical models with order-restricted inference.
  • Applies order-restricted estimation to parameters of a parsimonious mathematical model.
  • Evaluated through extensive simulations using dose-toxicity curves.

Main Results:

  • The hybrid method yields results comparable to existing methods for completely ordered groups.
  • The proposed method effectively generalizes to various partial orders among risk groups.
  • Simulations confirm the method's performance in dose-finding.

Conclusions:

  • Dose-finding in partially ordered groups remains an understudied area.
  • The proposed method is computationally feasible and practical.
  • Offers a viable solution for designing dose-finding studies in ordered and partially ordered groups.