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临床试验中生存分析的非劣效研究设计及R软件实现 被引量:1

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摘要 近年,非劣效性临床试验在药品开发中已有广泛的应用,统计学上关于试验药物相对于阳性对照药物的非劣效性评价方法已有多种,但主要集中在终点指标为二分类或正态连续型数据的临床试验。当观察指标为生存时间(survival time)时,可能包含截尾数据(censored data),则缺少相应的非劣效性评价方法,主要原因是生存分析设计背景下非劣效性的定义较为困难。本文拟介绍一种基于生存时间指数分布模型,假设对照组死亡风险率λ2与试验组死亡风险率λ1,之比为常数P,并在此基础上定义非劣效界值的分析方法,结合实例介绍其试验设计和统计检验方法,同时给出R软件实现程序。
出处 《中国卫生统计》 CSCD 北大核心 2013年第3期438-439,444,共3页 Chinese Journal of Health Statistics
基金 国家青年自然科学基金资助(81102201) 哈尔滨医科大学武连德青年基金(WLD-QN1105)
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  • 1Freitag G. Methods for assessing noninferiority with censored data. Bio-metrical Journal,2005,47(1) :88-98.
  • 2Fleming TR. Current issues in non-inferiority trials. Statistics in Medi-cine,2008,27 :317-332.
  • 3Rubinstein LV,Gail MH,Santner TJ. Planning the duration of a compar-ative clinical trial with loss to follow-up and a period of continued obser-vation. J Chron Dis,34:469-479.
  • 4Com-Nougue C,Rodary C,Patte C. How to establish equivalence whendata are censored : a randomized trial of treatments for n non-hodgkinlymphoma. Statistics in Medicine,1993,12 :1353-1364.
  • 5Bristol DR. Planning survival studies to compare a treatment to an activecontrol. Journal of Biopharmaceutical Statistics, 1993,3(2) :153-158.
  • 6D'Agostino SRB. Non-inferiority trials : advances in concepts and meth-odology. Statistics in Medicine,2003,22 : 165 -167.
  • 7Stallard N, Whitehead A. An alternative approach to the analysis of ani-mal carcinogenicity studies. Regulatory Toxicology and Pharmacology,1996,23:244-248.
  • 8Freitag G,Lange S,Munk A. Non-parametric assessment of non-inferiori-ty with censored data. Statistics in Medicine,2006,25 :1201-1217.
  • 9Tangen CM,Koch GG. Non-parametric covariance methods for incidencedensity analyses of time-to-event data from a randomized clinical trialand their complementary roles to proportional hazards regression. Statis-tics in Medicine,2000,19 : 1039-1058.

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