摘要
目的:探讨临床试验中组间不同删失比例对疗效评价的统计学性质的影响。方法:采用蒙特卡罗方法模拟两组生存数据,在不同删失比例的水平下,评价log-rank检验和Cox比例风险模型的假设检验和参数估计。结果:当两组删失比例相等时,I类错误最小,对风险比的估计值最准确,且检验效能也相对较高;在两组删失率较低,且删失率接近时,假设检验的结果可信度更高;但当两组删失率相差越来越大时,I类错误失控,且把握度亦受影响。结论:临床试验中运用生存分析,确保足够样本量的情况下删失率应控制在30%以内,并且建议两组删失率之差不要超过10%。
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 esti- mate the type I error and the test power of the log- rank test and Cox proportional hazards models in dif- ferent 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 cen- sored rate difference between two groups, the higher reliability hypothesis testing results. CONCLU- SION： In clinical trials, by ensuring enough sample size, the total censored rate should be controlled within 30%, and the difference of censored rate be- tween the two groups less than 10% was suggested.
作者
陈梦锴
柏建岭
魏永越
黄丽红
赵杨
于浩
CHEN Mengkai BAI Jianling WEI Yongyue HUANG Lihong ZHAO Yang YU Hao(Department of Biostatistics , School of Public Health , Nanjing Medical University , Nanjing 211166, Jiangsu , China)
出处
《中国临床药理学与治疗学》
CAS
CSCD
2017年第4期434-438,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
国家自然科学基金(81273184)
国家自然科学基金青年基金(81302512)
关键词
临床试验
删失率
生存分析
统计学性质
clinical trial
censored ratio
survival analysis
statistical property
