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Asymptotic validity of Schoenfeld’s sample size formula for the Cox proportional hazards model via the Wald test approach

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Analysis reveals limitations of Schoenfeld’s formula for sample size in survival trials, suggesting simulation-based methods instead.

This analysis aims to reassess the validity of Schoenfeld’s sample size formula for the Cox model under various conditions.
Revisit Schoenfeld's sample size formula.
Utilize a Wald test framework for evaluation.
Clarify conditions for asymptotic validity.
Perform a retrospective analysis of the ADAURA trial.
Demonstrated that Schoenfeld's formula may lose efficiency under certain assumptions.
Contrasted simulation-based methods as more robust in preserving efficiency.
Showed potential reduction in study duration using simulation-based power analysis.

Se Yoon Lee (2026) studied this question.

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