Assessing non-inferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity

被引：40
作者：
Hasler, Mario [1 ]
Vonk, Richardus [2 ]
Hothorn, Ludwig A. [1 ]
机构：
[1] Leibniz Univ Hannover, Inst Biostat, D-30419 Hannover, Germany
[2] Bayer Schering Pharma AG, Non Clin Stat, Berlin, Germany
来源：
STATISTICS IN MEDICINE | 2008年 / 27卷 / 04期
关键词：
heteroscedasticity; three-arm trial; non-inferiority; Fieller's confidence interval; optimal allocation;
D O I：
10.1002/sim.3052
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
In this paper, we describe an adjusted method to facilitate non-inferiority tests in a three-arm design. While the methodology is readily available in the situation of homogeneous group variances, the adjusted method will also maintain the alpha-level in the presence of heteroscedasticity. We propose explicit criteria for an optimal allocation. Depending on the pattern of heterogeneity, remarkably unbalanced designs are power optimal. We will apply the method to a randomized clinical trial and a toxicological experiment. Copyright (c) 2007 John Wiley & Sons, Ltd.
引用
收藏
页码：490 / 503
页数：14
相关论文
共 50 条
  • [41] Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial
    Liu, Lin
    Thorp, Steven R.
    Moreno, Lucy
    Wells, Stephanie Y.
    Glassman, Lisa H.
    Busch, Angela C.
    Zamora, Tania
    Rodgers, Carie S.
    Allard, Carolyn B.
    Morland, Leslie A.
    Agha, Zia
    JOURNAL OF TELEMEDICINE AND TELECARE, 2020, 26 (09) : 507 - 519
  • [42] Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
    Jacob Bodilsen
    Matthijs C. Brouwer
    Diederik van de Beek
    Pierre Tattevin
    Steven Tong
    Pontus Naucler
    Henrik Nielsen
    Trials, 22
  • [43] Test non-inferiority (and equivalence) based on the odds ratio under a simple crossover trial
    Lui, Kung-Jong
    Chang, Kuang-Chao
    STATISTICS IN MEDICINE, 2011, 30 (11) : 1230 - 1242
  • [44] Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
    Bodilsen, Jacob
    Brouwer, Matthijs C.
    van de Beek, Diederik
    Tattevin, Pierre
    Tong, Steven
    Naucler, Pontus
    Nielsen, Henrik
    TRIALS, 2021, 22 (01)
  • [45] Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice
    Emmerson, Jake
    Todd, Susan
    Brown, Julia M.
    TRIALS, 2021, 22 (01)
  • [46] Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice
    Jake Emmerson
    Susan Todd
    Julia M. Brown
    Trials, 22
  • [47] Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
    Lau, W.
    Chisholm, K.
    Gallagher, M. W.
    Felmingham, K.
    Murray, K.
    Pearce, A.
    Doyle, N.
    Alexander, S.
    O'Brien, H.
    Putica, A.
    Khatri, J.
    Bockelmann, P.
    Hosseiny, F.
    Librado, A.
    Notarianni, M.
    O'Donnell, M. L.
    CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, 2023, 33
  • [48] Demonstration of non-inferiority of a novel combination intramammary antimicrobial in the treatment of clinical mastitis
    Bryan, M. A.
    Hea, S. Y.
    Mannering, S. A.
    Booker, R.
    NEW ZEALAND VETERINARY JOURNAL, 2016, 64 (06) : 337 - 342
  • [49] Exact sample-size determination in testing non-inferiority under a simple crossover trial
    Lui, Kung-Jong
    Chang, Kuang-Chao
    PHARMACEUTICAL STATISTICS, 2012, 11 (02) : 129 - 134
  • [50] Minimization of sample size when comparing two small probabilities in a non-inferiority safety trial
    de Boo, TM
    Zielhuis, GA
    STATISTICS IN MEDICINE, 2004, 23 (11) : 1683 - 1699
12345