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June 1, 1983Biometrics1,105 citations

Sample-Size Formula for the Proportional-Hazards Regression Model

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DSDavid Schoenfeld

Key Points

  • The aim is to derive a sample-size formula for testing the equality of two survival distributions using concomitant information.
  • Derivation of a formula for sample size based on the proportional-hazards model.
  • Extension of Schoenfeld's asymptotic power results to incorporate concomitant information.
  • Computation of loss of efficiency due to the omission of concomitant variables.
  • The derived formula specifies the necessary sample size for adequate statistical power.
  • Incorporating concomitant information significantly improves estimation accuracy.
  • The analysis quantifies efficiency loss when ignoring relevant variables.

Abstract

A formula is derived for determining the number of observations necessary to test the equality of two survival distributions when concomitant information is incorporated. This formula should be useful in designing clinical trials with a heterogeneous patient population. Schoenfeld (1981, Biometrika 68, 316-319) derived the asymptotic power of a class of statistics used to test the equality of two survival distributions. That result is extended to the case where concomitant information is available for each individual and where the proportional-hazards model holds. The loss of efficiency caused by ignoring concomitant variables is also computed.

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Cite This Study

David Schoenfeld (1983) studied this question.

synapsesocial.com/papers/69d7605eb6e34cdcae48f52bhttps://doi.org/10.2307/2531021
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