When to stop treatment arms in a clinical trial assessing time to event with more than two arms against a common control

被引:0
|
作者
Grobler, Anneke C. [1 ]
Carrara, Henri R. O.
Mwambi, Henry G.
Parker, Robert A.
机构
[1] Univ KwaZulu Natal, Durban, South Africa
[2] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
关键词
sample-size calculation; three-arm trial; common control group; stopping rule; time-to-event analysis;
D O I
10.1177/0163278707304037
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Two-arm time-to-event (or survival) trials are powered to continue until a required number of events is reached. The authors discuss how the required number of events should be defined for a study with three or more arms with various pairwise comparisons and a common control arm. They advocate stopping one active arm when the required number of events is observed in the applicable pairwise comparison but continuing with the other active arm and the control arm until the required number of events is observed in that pairwise comparison, thereby ensuring that the study continues until enough events are observed in each pairwise comparison. This article is the result of considerations during the design of a three-arm microbicide trial.
引用
收藏
页码:284 / 299
页数:16
相关论文
共 9 条
  • [1] When Ethics Constrains Clinical Research: Trial Design of Control Arms in "Greater Than Minimal Risk" Pediatric Trials
    de Melo-Martin, Inmaculada
    Sondhi, Dolan
    Crystal, Ronald G.
    [J]. HUMAN GENE THERAPY, 2011, 22 (09) : 1121 - 1127
  • [2] The Multiple Propensity Score as Control for Bias in the Comparison of More Than Two Treatment Arms An Introduction From a Case Study in Mental Health
    Spreeuwenberg, Marieke Dingena
    Bartak, Anna
    Croon, Marcel A.
    Hagenaars, Jacques A.
    Busschbach, Jan J. V.
    Andrea, Helene
    Twisk, Jos
    Stijnen, Theo
    [J]. MEDICAL CARE, 2010, 48 (02) : 166 - 174
  • [3] Extending the classification approach for comparing two active treatment arms to binary and time-to-event outcomes
    Liu, Jingyi
    Qu, Yongming
    Kulkarni, Pandurang M.
    [J]. JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2017, 27 (04) : 584 - 594
  • [4] Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial
    Ahi, Mohammadreza
    Farahani, Ramin Hamidi
    Basiri, Pouria
    Rahjerdi, Ahmad Karimi
    Sheidaei, Ali
    Gohari, Kimiya
    Rahimi, Zahra
    Gholami, Fatemeh
    Moradi, Milad
    Naeeni, Farzad Ghafoori
    Saffar, Kosar Naderi
    Ghasemi, Soheil
    Barati, Babak
    Moradi, Sohrab
    Monazah, Arina
    Pouranvari, Fatemeh
    Forooghizadeh, Mohsen
    [J]. VACCINES, 2022, 10 (11)
  • [5] Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms
    Farassat, Navid
    Boehringer, Daniel
    Kuechlin, Sebastian
    Molnar, Fanni E.
    Schwietering, Anne
    Seger, Dorina
    Hug, Martin J.
    Knoebel, Anja-Birte
    Schneider-Fuchs, Sabine
    Ihorst, Gabriele
    Wabbels, Bettina
    Beisse, Christina
    Ziemssen, Focke
    Schuettauf, Frank
    Hedergott, Andrea
    Ring-Mangold, Theresia
    Schuart, Claudia
    Wolf, Armin
    Schmickler, Stefanie
    Biermann, Julia
    Eberwein, Philipp
    Hufendiek, Karsten
    Eckstein, Anja
    Gusek-Schneider, Gabriele
    Schittkowski, Michael
    Lischka, Thomas
    Lagreze, Wolf A.
    [J]. BMJ OPEN, 2023, 13 (04):
  • [6] Case management in a web-based cognitive and motor treatment for patients with mild cognitive impairment: A study protocol of a multicentric, randomized, two parallel arms controlled clinical trial
    Gallucci, Alessia
    Tuena, Cosimo
    Bruni, Francesca
    Fedecostante, Massimiliano
    Rossi, Lorena
    Greco, Antonio
    Tettamanti, Mauro
    Lattanzio, Fabrizia
    Stramba-Badiale, Marco
    Giunco, Fabrizio
    Trimarchi, Pietro Davide
    [J]. DIGITAL HEALTH, 2024, 10
  • [7] Effects of Anti-Inflammatory Treatment and Surgical Intervention on Endothelial Glycocalyx, Peripheral and Coronary Microcirculatory Function and Myocardial Deformation in Inflammatory Bowel Disease Patients: A Two-Arms Two-Stage Clinical Trial
    Triantafyllou, Charilaos
    Nikolaou, Maria
    Ikonomidis, Ignatios
    Bamias, Giorgos
    Kouretas, Dimitrios
    Andreadou, Ioanna
    Tsoumani, Maria
    Thymis, John
    Papaconstantinou, Ioannis
    [J]. DIAGNOSTICS, 2021, 11 (06)
  • [8] A tight control treatment strategy aiming for remission in early rheumatoid arthritis is more effective than usual care treatment in daily clinical practice: a study of two cohorts in the Dutch Rheumatoid Arthritis Monitoring registry
    Schipper, Lydia G.
    Vermeer, Marloes
    Kuper, Hillechiena H.
    Hoekstra, Monique O.
    Haagsma, Cees J.
    Den Broeder, Alfons A.
    van Riel, Piet
    Fransen, Jaap
    van de Laar, Mart A. F. J.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2012, 71 (06) : 845 - 850
  • [9] A Tight Control Treatment Strategy Aiming for Remission in Early Rheumatoid Arthritis Is More Effective than Usual Care Treatment in Daily Clinical Practice: A Study of Two Cohorts in the Dutch Rheumatoid Arthritis Monitoring Registry
    Lunzer, R.
    [J]. JOURNAL FUR MINERALSTOFFWECHSEL, 2013, 20 (01): : 23 - 23