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Huang LH, Bai JL, Yu H, et al. Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials. J Biomed Res. 2017;doi: 10.7555/JBR.31.20160111.
Huang, L. H., Bai, J. L., Yu, H., & Chen, F. (2017). Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials. Journal of biomedical research, . https://doi.org/10.7555/JBR.31.20160111
Huang, Li-hong, et al. "Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials." Journal of biomedical research vol. (2017). doi: https://doi.org/10.7555/JBR.31.20160111
Huang LH, Bai JL, Yu H, Chen F. Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials. J Biomed Res. 2017 Jun 20; doi: 10.7555/JBR.31.20160111. Epub 2017 Jun 20. PMID: 28630393; PMCID: PMC5956254.
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J Biomed Res. 2017 Jun 20; doi: 10.7555/JBR.31.20160111. Epub 2017 Jun 20.

Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials.

Journal of biomedical research

Li-hong Huang, Jian-ling Bai, Hao Yu, Feng Chen

Affiliations

  1. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu 211166, China.
  2. Ministry of Education Key Laboratory for Modern Toxicology, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu 211166, China.

PMID: 28630393 PMCID: PMC5956254 DOI: 10.7555/JBR.31.20160111

Abstract

Sample size re-estimation is essential in oncology studies. However, the use of blinded sample size reassessment for survival data has been rarely reported. Based on the density function of the exponential distribution, an expectation-maximization (EM) algorithm of the hazard ratio was derived, and several simulation studies were used to verify its applications. The method had obvious variation in the hazard ratio estimates and overestimation for the relatively small hazard ratios. Our studies showed that the stability of the EM estimation results directly correlated with the sample size, the convergence of the EM algorithm was impacted by the initial values, and a balanced design produced the best estimates. No reliable blinded sample size re-estimation inference can be made in our studies, but the results provide useful information to steer the practitioners in this field from repeating the same endeavor..

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