Designing Multiregional Trials Under the Discrete Random Effects Model

Designing Multiregional Trials Under the Discrete Random Effects Model

A discrete random effects model (Lan and Pinheiro, 2012 ) was proposed recently for multiregional clinical trials for continuous responses. This article elucidates further the application of this model to time-to-event and binary responses. We provide some guidelines on how to design multiregional t...

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Veröffentlicht in:Journal of biopharmaceutical statistics 2014-03, Vol.24 (2), p.415-428
Hauptverfasser: Lan, K.-K. Gordon, Pinheiro, José, Chen, Fei
Format: Artikel
Sprache:eng
Schlagworte:
Clinical trials
Discrete random effects model
Endpoint Determination - methods
Endpoint Determination - statistics & numerical data
Guidelines
Humans
Local area networks
Meta-analysis
Meta-Analysis as Topic
Models, Theoretical
Multicenter Studies as Topic - methods
Multicenter Studies as Topic - statistics & numerical data
Multiregional clinical trial design
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - statistics & numerical data
Research Design - statistics & numerical data
Statistics
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Beschreibung
Zusammenfassung:A discrete random effects model (Lan and Pinheiro, 2012 ) was proposed recently for multiregional clinical trials for continuous responses. This article elucidates further the application of this model to time-to-event and binary responses. We provide some guidelines on how to design multiregional trials and also show how the same model lends itself naturally to meta-analysis.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543406.2013.860155