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Related Experiment Videos

Early selection in a randomized phase II clinical trial.

Seth M Steinberg1, David J Venzon

  • 1Biostatistics and Data Management Section, Office of the Director, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 702, MSC 8325, Bethesda, MD 20892-8325, USA. ss118v@nih.gov

Statistics in Medicine
|July 12, 2002
PubMed
Summary

This study introduces a new method for randomized phase II clinical trials. It allows early stopping and selection of the best treatment arm for further study based on statistical selection theory.

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Medical Research

Background:

  • Randomized phase II trials are used to select therapies for phase III studies.
  • Existing methods require formal superiority testing, which may not be necessary for selection.
  • Previous work by Simon, Wittes, and Ellenberg provided sample size calculations for selecting a superior arm.

Purpose of the Study:

  • To describe a statistical selection theory approach for randomized phase II trials.
  • To enable early stopping of accrual at an interim point.
  • To select one of two treatment arms for subsequent phase III evaluation.

Main Methods:

  • Utilizing statistical selection theory for decision-making.
  • Implementing an interim analysis to assess treatment arm performance.

Related Experiment Videos

  • Defining criteria for early stopping and arm selection based on response rates.

    • Main Results:

    • The proposed method allows for potential early termination of patient accrual.
    • It facilitates the selection of one of two arms for further investigation.
    • Requires a significant difference in response rates at the interim point to minimize selection of an inferior arm.

    Conclusions:

    • This approach offers an alternative to traditional hypothesis testing in phase II trials.
    • It provides a framework for efficient selection of promising therapies.
    • The method aims to reduce the probability of selecting a suboptimal treatment for phase III studies.