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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2017, Vol. 22 ›› Issue (4): 434-438.

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Effect of difference censored rates between groups in clinical trails

CHEN Mengkai, BAI Jianling, WEI Yongyue, HUANG Lihong, ZHAO Yang, YU Hao   

  1. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, China
  • Received:2016-12-22 Revised:2017-02-21 Online:2017-04-26 Published:2017-04-26

Abstract:

AIM: To explore the influence on the results of survival analysis when the censored rates are different between the groups. METHODS: Monte-Carlo method was used to simulate a two-group survival data in clinical trials and to estimate the type I error and the test power of the log-rank test and Cox proportional hazards models in different scenario of different censored rates between groups. RESULTS: If censored rates were equal in both test group and control group, the type I errors were well controlled, the estimates of HR were most accurate, and the power was relatively high. If total censored rates were lower than 30%, the lower censored rate difference between two groups, the higher reliability hypothesis testing results. CONCLUSION: In clinical trials, by ensuring enough sample size, the total censored rate should be controlled within 30%, and the difference of censored rate between the two groups less than 10% was suggested.

Key words: clinical trial, censored ratio, survival analysis, statistical property

CLC Number: