Informative priors or noninformative priors? A Bayesian re-analysis of binary data from Macugen phase III clinical trials

被引:2
|
作者
Chen, Ding-Geng [1 ,2 ,3 ]
Ting, Naitee [4 ]
Ho, Shuyen [5 ]
机构
[1] Univ N Carolina, Sch Social Work, Chapel Hill, NC USA
[2] Univ N Carolina, Gillings Sch Global Publ Hlth, Dept Biostat, Chapel Hill, NC USA
[3] Univ Pretoria, Dept Stat, Pretoria, South Africa
[4] Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA
[5] PAREXEL Int E, Durham, NC USA
关键词
Age-related macular degeneration; Beta-binomial; Bayesian posterior distribution; Frequentist p-values; Hypergeometric function; Monte-Carlo simulation;
D O I
10.1080/03610918.2015.1122049
中图分类号
O21 [概率论与数理统计]; C8 [统计学];
学科分类号
020208 ; 070103 ; 0714 ;
摘要
It has became more popular in the recent statistical literature to see Bayesian approaches for clinical trials, such as assurance calculations for study designs and the use of posterior probability for data analyses. When applying Bayesian analysis to clinical trial data, one common question is to use informative priors or noninformative priors. In order to explore this question, we looked for existing clinical trial data with a simple structure and a simple clinical endpoint so that the Bayesian re-analyses can be easily performed. We came across the published Phase III Macugen (R) data that were suitable for this exploration. In this manuscript, the Macugen Phase III development program was described, the primary data for the two Phase III pivotal studies were re-analyzed using Bayesian applications with informative priors and noninformative priors. These re-analysis results were summarized, compared, and discussed.
引用
收藏
页码:4535 / 4546
页数:12
相关论文
共 50 条
  • [31] Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials
    Jabbour, Serge
    Seufert, Jochen
    Scheen, Andre
    Bailey, Clifford J.
    Karup, Cathrina
    Langkilde, Anna M.
    DIABETES OBESITY & METABOLISM, 2018, 20 (03): : 620 - 628
  • [32] Population analysis of data obtained in phase I-III clinical trials of HBOC-201.
    Knebel, W
    Pearce, LB
    Gawryl, MS
    Pentikis, HS
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2003, 73 (02) : P67 - P67
  • [33] Ixabepilone-associated peripheral neuropathy: data from across the phase II and III clinical trials
    Linda T. Vahdat
    Eva S. Thomas
    Henri H. Roché
    Gabriel N. Hortobagyi
    Joseph A. Sparano
    Louise Yelle
    Monica N. Fornier
    Miguel Martín
    Craig A. Bunnell
    Pralay Mukhopadhyay
    Ronald A. Peck
    Edith A. Perez
    Supportive Care in Cancer, 2012, 20 : 2661 - 2668
  • [34] Adverse events during clinical trials comparing leflunomide, methotrexate, sulfasalazine and placebo. meta-analysis of data from phase II and III controlled clinical trials
    Cannon, GW
    Strand, V
    Oed, C
    Scarazzini, L
    Holden, WL
    ANNALS OF THE RHEUMATIC DISEASES, 2004, 63 : 252 - 253
  • [35] Ixabepilone-associated peripheral neuropathy: data from across the phase II and III clinical trials
    Vahdat, Linda T.
    Thomas, Eva S.
    Roche, Henri H.
    Hortobagyi, Gabriel N.
    Sparano, Joseph A.
    Yelle, Louise
    Fornier, Monica N.
    Martin, Miguel
    Bunnell, Craig A.
    Mukhopadhyay, Pralay
    Peck, Ronald A.
    Perez, Edith A.
    SUPPORTIVE CARE IN CANCER, 2012, 20 (11) : 2661 - 2668
  • [36] Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial
    Chen, Jia
    Xiong, Jianping
    Wang, Jiejun
    Zheng, Leizhen
    Gao, YanFei
    Guan, Zhongzhen
    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2018, 14 (05) : e310 - e316
  • [37] The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder
    Anneke C. Grobler
    Glenda Matthews
    Geert Molenberghs
    Psychopharmacology, 2014, 231 : 1987 - 1999
  • [38] The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder
    Grobler, Anneke C.
    Matthews, Glenda
    Molenberghs, Geert
    PSYCHOPHARMACOLOGY, 2014, 231 (09) : 1987 - 1999
  • [39] Is S-Adenosyl Methionine (SAMe) for Depression Only Effective in Males? A Re-Analysis of Data from a Randomized Clinical Trial
    Sarris, J.
    Price, L. H.
    Carpenter, L. L.
    Tyrka, A. R.
    Ng, C. H.
    Papakostas, G. I.
    Jaeger, A.
    Fava, M.
    Mischoulon, D.
    PHARMACOPSYCHIATRY, 2015, 48 (4-5) : 141 - 144
  • [40] Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn's Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials
    Fasanmade, Adedigbo A.
    Adedokun, Omoniyi J.
    Blank, Marion
    Zhou, Honghui
    Davis, Hugh M.
    CLINICAL THERAPEUTICS, 2011, 33 (07) : 946 - 964