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Shift models for dose-finding in partially ordered groups.

Bethany Jablonski Horton1, Nolan A Wages1, Mark R Conaway1

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

Clinical Trials (London, England)
|October 13, 2018
PubMed
Summary
This summary is machine-generated.

A new two-stage continual reassessment method (CRM) allows for group-specific dose selection in clinical trials with partially ordered groups. This method ensures maximum tolerated dose (MTD) order aligns with known group frailty, improving accuracy and accessibility.

Keywords:
Clinical trialscontinual reassessment methoddose-finding studiesmaximum tolerated dosepartially ordered groupsphase I designs

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Pharmacology

Background:

  • Limited methods exist for dose-finding in clinical trials requiring group-specific dose selection.
  • Parallel trials offer group-specific dose selection but may not align with known group order information.

Purpose of the Study:

  • To develop a novel two-stage continual reassessment method (CRM) for dose-finding in studies with three or more groups exhibiting a partial order based on known frailty.
  • To enable maximum tolerated dose (MTD) selection that respects the known frailty order among groups.

Main Methods:

  • The proposed method extends the CRM shift model for two ordered groups to handle partially ordered groups.
  • It allows for dose selection by group, ensuring MTDs follow the established frailty order.

Main Results:

  • Simulation studies demonstrated that ignoring group frailty order in independent CRM trials led to out-of-order MTD selection in 30% of cases.
  • The proposed two-stage CRM for partially ordered groups more frequently selected the MTD and assigned more patients to it compared to independent trials.
  • Performance was comparable to a less computationally accessible existing method.

Conclusions:

  • The developed CRM for partially ordered groups ensures correct MTD order and enhances selection accuracy.
  • This method provides a computationally accessible solution for dose-finding in complex clinical trial settings.