Methods for assessing noninferiority with censored data

被引:9
作者
Freitag, G [1 ]
机构
[1] Univ Gottingen, Inst Math Stochast, D-37073 Gottingen, Germany
关键词
bootstrap; confidence interval; noninferiority; nonparametrics; odds ratio; survival distribution; therapeutic equivalence;
D O I
10.1002/bimj.200410083
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
In this paper we present the existing approaches to the problem of showing noninferiority with randomly right censored data. The main focus is on the choice of the discrepancy measure which is used to define the deviation from the classical null hypothesis, i.e. the noninferiority margin. Most methods are based on certain parametric or semiparametric assumptions. In contrast, a new, completely nonparametric approach is suggested and discussed.
引用
收藏
页码:88 / 98
页数:11
相关论文
共 31 条
[1]   Nonparametric Tests for Comparing Two Mean Residual Life Functions [J].
Aly E.-E.A.A. .
Lifetime Data Analysis, 1997, 3 (4) :353-366
[2]  
[Anonymous], 1999, STAT MED, V18, P1905
[3]   MULTI-PARAMETER HYPOTHESIS-TESTING AND ACCEPTANCE SAMPLING [J].
BERGER, RL .
TECHNOMETRICS, 1982, 24 (04) :295-300
[4]  
Bristol D R, 1993, J Biopharm Stat, V3, P153
[5]   A score test for establishing non-inferiority with respect to short-term survival in two-sample comparisons with identical proportions of long-term survivors [J].
Broët, P ;
Tubert-Bitter, P ;
De Rycke, Y ;
Moreau, T .
STATISTICS IN MEDICINE, 2003, 22 (06) :931-940
[6]  
COMNOUGUE C, 1995, REV EPIDEMIOL SANTE, V43, P84
[7]  
COMNOUGUE C, 1993, STAT MED, V12, P1353, DOI 10.1002/sim.4780121407
[8]  
*CPMP, 2004, CPMPEWP215899
[9]  
DAGOSTINO RB, 2003, STAT MED, V22
[10]   AN ELEMENTARY APPROACH TO WEAK-CONVERGENCE FOR QUANTILE PROCESSES, WITH APPLICATIONS TO CENSORED SURVIVAL-DATA [J].
DOSS, H ;
GILL, RD .
JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1992, 87 (419) :869-877