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Related Experiment Videos

Randomization in cancer clinical trials: permutation test and development of a computer program.

Y Ohashi1

  • 1University Hospital Computer Center, University of Tokyo Hospital, Japan.

Environmental Health Perspectives
|July 1, 1990
PubMed
Summary

Ignoring dynamic balancing in cancer clinical trials leads to conservative results. A new program uses permutation tests for minimization or stratified block designs, improving analysis accuracy.

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Area of Science:

  • Biostatistics
  • Clinical Trials
  • Cancer Research

Background:

  • Dynamic balancing methods like minimization are used in cancer clinical trials to ensure balanced prognostic factors.
  • Ignoring these complex randomization schemes in analysis can lead to overly conservative statistical results.

Purpose of the Study:

  • To demonstrate the conservativeness of standard analysis methods when dynamic balancing is ignored.
  • To introduce a computer program for permutation tests suitable for minimization or stratified permuted block designs in cancer trials.
  • To address data management challenges in Japanese cancer clinical trials.

Main Methods:

  • Computer simulations were used to demonstrate the conservativeness of ignoring dynamic balancing.
  • A computer program was developed to perform permutation tests on log-rank statistics for minimization and stratified permuted block designs.

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  • International guidelines for data management in bladder cancer trials were reviewed.

    • Main Results:

    • Computer simulations confirmed that ignoring dynamic balancing in cancer trial analysis leads to conservative outcomes.
    • The developed program provides a method to supplement standard stratified and model-based analyses.
    • Differences in data management systems between US/European and Japanese centers were highlighted.

    Conclusions:

    • Accurate statistical analysis of cancer clinical trials requires accounting for dynamic balancing methods.
    • The developed permutation test program offers a valuable tool for improving the reliability of cancer trial results.
    • Standardizing data management practices is crucial for international collaborative cancer research.