One-stage and two-stage designs for clinical trials using an indifference-zone approach

被引:1
|
作者
Koyama, N
Hayter, AJ
机构
[1] Sankyo Co Ltd, New Drug Dev Div, Biostat Sect, Shinagawa Ku, Tokyo 1408710, Japan
[2] Georgia Inst Technol, Sch Ind & Syst Engn, Atlanta, GA 30332 USA
关键词
selection probability; selection rule; least favorable configuration; interim analysis;
D O I
10.1081/SAC-120013124
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
In new drug development we often need to select experimental. treatments which are better than a control treatment for further development. Many statistical selection procedures are proposed for choosing optimal treatments in clinical trial's since such procedures are very simple and the required number of patients is smaller than that of test-based methods. However most of these methods focus on selecting the best treatment or on selecting a subset containing all treatments better than the control. It may sometimes be more reasonable to select all treatments better than the control and no treatment worse than the control in order to avoid assigning patients to inferior treatments in later trials. In this article, we consider the one-stage and two-stage designs for choosing all the treatments whose response probabilities are greater than a control. Some numerical results and examples are also shown and the advantages of the two-stage design in decreasing the number of patients are discussed.
引用
收藏
页码:241 / 257
页数:17
相关论文
共 50 条
  • [1] One-stage and two-stage designs for phase II clinical trials with survival endpoints
    Whitehead, John
    STATISTICS IN MEDICINE, 2014, 33 (22) : 3830 - 3843
  • [2] One-stage Versus Two-stage Exchange
    Lichstein, Paul
    Gehrke, Thorsten
    Lombardi, Adolph
    Romano, Carlo
    Stockley, Ian
    Babis, George
    Bialecki, Jerzy
    Bucsi, Laszlo
    Cai, Xu
    Cao, Li
    de Beaubien, Brian
    Erhardt, Johannes
    Goodman, Stuart
    Jiranek, William
    Keogh, Peter
    Lewallen, David
    Manner, Paul
    Marczynski, Wojciech
    Mason, J. Bohannon
    Mulhall, Kevin
    Paprosky, Wayne
    Patel, Preetesh
    Piccaluga, Francisco
    Polkowski, Gregory
    Pulido, Luis
    Stockley, Ian
    Suarez, Juan
    Thorey, Fritz
    Tikhilov, Rashid
    Velazquez, Job Diego
    Winkler, Heinz
    JOURNAL OF ORTHOPAEDIC RESEARCH, 2014, 32 : S141 - S146
  • [3] One- and two-stage designs for stratified phase II clinical trials
    London, WB
    Chang, MN
    STATISTICS IN MEDICINE, 2005, 24 (17) : 2597 - 2611
  • [4] TWO-STAGE DESIGNS IN RANDOMIZED PHARMACOGENETIC CLINICAL TRIALS
    Yu, M.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 85 : S79 - S79
  • [5] Shoulder and elbow arthroplasty: One-stage or two-stage
    Rozing, Piet M.
    Nagels, Jochern
    JOURNAL OF SHOULDER AND ELBOW SURGERY, 2008, 17 (01) : 9 - 13
  • [6] Two-stage designs in bioequivalence trials
    Helmut Schütz
    European Journal of Clinical Pharmacology, 2015, 71 : 271 - 281
  • [7] Two-stage designs in bioequivalence trials
    Schuetz, Helmut
    EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2015, 71 (03) : 271 - 281
  • [8] Brachymetatarsia One-stage Versus Two-Stage Procedures
    Shecaira, Andre Perin
    Pacheco Fernandes, Rodrigo Mota
    FOOT AND ANKLE CLINICS, 2019, 24 (04) : 677 - +
  • [9] Two-stage versus one-stage - Is there really a controversy?
    Garber, DA
    Salama, H
    Salama, MA
    JOURNAL OF PERIODONTOLOGY, 2001, 72 (03) : 417 - 421
  • [10] An Ensemble of One-Stage and Two-Stage Detectors Approach for Road Damage Detection
    Ding, Wenchao
    Zhao, Xu
    Zhu, Bingke
    Du, Yinglong
    Zhu, Guibo
    Yu, Tao
    Li, Lei
    Wang, Jinqiao
    Proceedings - 2022 IEEE International Conference on Big Data, Big Data 2022, 2022, : 6395 - 6400