Sample size calculation for a proportional hazards mixture cure model with nonbinary covariates

Yihong Zhan, Yanan Zhang, Jiajia Zhang, Bo Cai and James W. Hardin

Journal of Applied Statistics, 2019, vol. 46, issue 3, 468-483

Abstract: Sample size calculation is a critical issue in clinical trials because a small sample size leads to a biased inference and a large sample size increases the cost. With the development of advanced medical technology, some patients can be cured of certain chronic diseases, and the proportional hazards mixture cure model has been developed to handle survival data with potential cure information. Given the needs of survival trials with potential cure proportions, a corresponding sample size formula based on the log-rank test statistic for binary covariates has been proposed by Wang et al. [25]. However, a sample size formula based on continuous variables has not been developed. Herein, we presented sample size and power calculations for the mixture cure model with continuous variables based on the log-rank method and further modified it by Ewell's method. The proposed approaches were evaluated using simulation studies for synthetic data from exponential and Weibull distributions. A program for calculating necessary sample size for continuous covariates in a mixture cure model was implemented in R.

Date: 2019
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DOI: 10.1080/02664763.2018.1498463

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