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A placebo-controlled Bayesian dose finding design based on continuous reassessment method with application to stroke

Chunyan Cai1,2, Mohammad H Rahbar1,2,3, Md Monir Hossain4

  • 1Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX 77030, USA.

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This study introduces a novel dose-finding design for clinical trials, incorporating control group data to accurately determine the maximum tolerated dose of pioglitazone in stroke patients. The method enhances precision in identifying optimal drug dosages for future research.

Keywords:
Continuous reassessment methodDose findingPlacebo-controlled studyStroke research

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Area of Science:

  • Clinical Trials Methodology
  • Pharmacology
  • Neurology

Background:

  • Traditional dose-finding studies often exclude control groups.
  • The Safety of Pioglitazone for hematoma resolution in intracerebral hemorrhage (SHRINC) trial requires a robust dose-finding method.
  • Spontaneous intracerebral hemorrhage presents unique challenges for treatment optimization.

Purpose of the Study:

  • To develop and evaluate a novel dose-finding design for pioglitazone in stroke patients with intracerebral hemorrhage.
  • To identify the maximum tolerated dose (MTD) of pioglitazone.
  • To incorporate control group data into the dose-finding framework.

Main Methods:

  • Developed an extension of the continuous reassessment method.
  • Incorporated information from the control group (standard of care).
  • Conducted extensive simulation studies to evaluate operating characteristics.

Main Results:

  • The proposed dose-finding design is robust and performs well in simulations.
  • Estimating toxicity rate in the control group improved accuracy of natural history data.
  • Enabled identification of an appropriate dose for the next study phase.

Conclusions:

  • The novel design effectively incorporates control group data into dose-finding.
  • This approach enhances the precision of MTD determination in clinical trials.
  • Provides a valuable tool for future trials with similar objectives, particularly in neurology.