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How to design a dose-finding study using the continual reassessment method.

Graham M Wheeler1, Adrian P Mander2, Alun Bedding3

  • 1Cancer Research UK and UCL Cancer Trials Centre, University College London, 90 Tottenham Court Road, London, W1T 4TJ, UK. graham.wheeler@ucl.ac.uk.

BMC Medical Research Methodology
|January 20, 2019
PubMed
Summary
This summary is machine-generated.

The Continual Reassessment Method (CRM) offers more accurate maximum tolerated dose (MTD) identification in phase I trials than traditional methods. This guide provides a framework and practical tools to increase CRM adoption in clinical research.

Keywords:
Adaptive designsContinual reassessment methodDose escalationDose-findingMaximum tolerated dosePhase I trials

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Pharmacology

Background:

  • The Continual Reassessment Method (CRM) is a model-based design for phase I trials to identify the maximum tolerated dose (MTD).
  • CRM is more accurate and efficient in targeting the MTD compared to traditional 3+3 designs.
  • Slow adoption of CRM in clinical research poses risks to patients and drug development due to a lack of practical guidance.

Purpose of the Study:

  • To address barriers hindering CRM adoption by providing a structured framework and practical resources.
  • To guide clinicians and statisticians in designing and conducting dose-finding studies using the CRM.
  • To improve the application of CRM in phase I trials.

Main Methods:

  • Developed a structured framework for designing CRM-based dose-finding studies.
  • Provided recommendations for key design parameters and pre-trial simulation.
  • Included practical tools such as software recommendations and template protocol text.

Main Results:

  • Presented initial design recommendations to facilitate the CRM design process.
  • Included case studies of two published CRM trials, analyzing their design, conduct, and outcomes.
  • Compared CRM trial outcomes to hypothetical 3+3 designs.

Conclusions:

  • The provided framework and resources aim to equip clinicians and statisticians new to CRM.
  • This guidance is expected to enhance the uptake and effective implementation of the CRM in phase I dose-finding trials.
  • Facilitating CRM use can lead to more accurate MTD identification and improved patient safety.