A parametric framework for assessing and estimating sufficient follow-up time in cure models

Abstract

Reliable estimation of cure fractions depends critically on adequate follow-up. Classical procedures for assessing follow-up sufficiency are primarily inferential, whereas a separate body of literature estimates time to cure using excess-hazard, conditional cure-probability, or residual-survival definitions. These two approaches remain largely disconnected: assessing the adequacy of observed follow-up does not generally quantify the additional follow-up required under an explicit tolerance, whereas estimating time to cure does not itself provide a formal inferential assessment of the available follow-up. We develop a unified parametric framework that combines the Parametric Follow-up Sufficiency Test, which compares the terminal Kaplan-Meier estimate with the cure fraction estimated from a parametric mixture cure model, with two complementary tolerance-based formulations: the Plateau Distance Criterion on the population survival scale and the Residual Survival Criterion on the susceptible survival scale. We derive closed-form expressions for both criteria under the Weibull mixture cure model and establish that they yield identical minimum follow-up times under an appropriate transformation of their tolerance parameters. We evaluate the finite-sample performance of the framework through Monte Carlo simulations across sample sizes, cure fractions, and administrative censoring scenarios. Applications to prostate cancer and triple-negative breast cancer data illustrate how the framework assesses available follow-up, estimates additional observation time under prespecified tolerances, and identifies settings in which follow-up is already adequate.