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Sample size considerations for studies comparing survival curves using historical controls.

D O Dixon1, R Simon

  • 1National Cancer Institute, Bethesda, MD 20892.

Journal of Clinical Epidemiology
|January 1, 1988
PubMed
Summary

This study presents methods for calculating the necessary sample size for survival curve comparisons, even when some control patients are already enrolled. It provides straightforward calculations and examples for efficient clinical trial planning.

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Area of Science:

  • Biostatistics
  • Clinical Trials
  • Survival Analysis

Background:

  • Prospective studies comparing survival curves often require precise sample size calculations.
  • Existing methods may not fully account for scenarios where control group patients have pre-existing follow-up data.
  • Efficient sample size determination is crucial for resource allocation and study validity.

Purpose of the Study:

  • To derive formulas for determining the required sample size in prospective survival curve comparisons.
  • To address the specific situation where control group patients have already undergone some follow-up.
  • To provide practical guidance and examples for sample size calculations in such clinical trial designs.

Main Methods:

  • Formulas were derived for sample size calculation in survival analysis.

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  • The methods account for existing follow-up data in the control group.
  • Computational procedures are outlined, and illustrative tables are provided.

    • Main Results:

    • Formulas enable the determination of patient numbers needed for survival curve comparisons with pre-followed controls.
    • While explicit formulas for sample size are not directly provided, the calculation process is simplified.
    • Examples and tables facilitate the application of these methods.

    Conclusions:

    • The derived methods offer a practical approach to sample size determination in survival studies with partially followed control groups.
    • The findings support efficient clinical trial design by optimizing patient allocation.
    • Consideration is given to scenarios requiring allocation of new patients to the control arm.