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Related Experiment Videos

Evaluation of randomized discontinuation design.

Boris Freidlin1, Richard Simon

  • 1Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892-7434, USA. freidlinb@ctep.nci.nih.gov

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|June 29, 2005
PubMed
Summary

Randomized discontinuation designs can be effective for early development of targeted cytostatic agents when patient selection assays are unavailable. Careful planning is crucial for optimizing these early-phase clinical trial designs.

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Area of Science:

  • Oncology
  • Clinical Trial Design
  • Pharmacology

Background:

  • Single-arm phase II trials may lack power for evaluating cytostatic agents.
  • Early development of targeted cytostatic agents requires robust clinical trial designs.

Purpose of the Study:

  • To evaluate two randomized designs: randomized discontinuation and upfront randomization.
  • To assess the suitability of these designs for early-phase targeted cytostatic agent development.

Main Methods:

  • Comparison of the statistical power of randomized discontinuation and upfront randomization designs.
  • Modeling of treatment effects for targeted cytostatic agents under different scenarios.

Main Results:

  • Upfront randomization is more efficient if the agent has a fixed effect on tumor growth or benefits slower-growing tumors.

Related Experiment Videos

  • Randomized discontinuation designs show potential when only a subset of patients is sensitive to the agent, requiring careful parameter structuring for patient enrichment.

    • Conclusions:

    • Randomized discontinuation designs can be valuable for early targeted agent development, especially when patient selection assays are not yet available.
    • Effective implementation requires careful planning and parameter optimization to ensure patient enrichment.