scholarly journals Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints

2021 ◽  
pp. 1-17
Author(s):  
Tianyu Zhan ◽  
Yiwang Zhou ◽  
Ziqian Geng ◽  
Yihua Gu ◽  
Jian Kang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Multiple Endpoints ◽  
Control Information ◽  
Confirmatory Clinical Trials

Unified exact design with early stopping rules for single arm clinical trials with multiple endpoints

2021 ◽  
pp. 096228022110130
Author(s):  
Wei Wei ◽  
Denise Esserman ◽  
Michael Kane ◽  
Daniel Zelterman
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Decision Rules ◽  
Stopping Rules ◽  
Multiple Endpoints ◽  
Shiny App ◽  
R Shiny ◽  
Early Phase Clinical Trials ◽  
User Friendly ◽  
Exact Design

Adaptive designs are gaining popularity in early phase clinical trials because they enable investigators to change the course of a study in response to accumulating data. We propose a novel design to simultaneously monitor several endpoints. These include efficacy, futility, toxicity and other outcomes in early phase, single-arm studies. We construct a recursive relationship to compute the exact probabilities of stopping for any combination of endpoints without the need for simulation, given pre-specified decision rules. The proposed design is flexible in the number and timing of interim analyses. A R Shiny app with user-friendly web interface has been created to facilitate the implementation of the proposed design.

Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan

2019 ◽  
pp. 216847901985599
Author(s):  
Kentaro Sakamaki ◽  
Seitaro Yoshida ◽  
Yusuke Morita ◽  
Toshifumi Kamiura ◽  
Katsuhiro Iba ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Multiple Endpoints ◽  
Industry Survey
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