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

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

2020 ◽  
Vol 54 (3) ◽  
pp. 528-533
Author(s):  
Kentaro Sakamaki ◽  
Seitaro Yoshida ◽  
Yusuke Morita ◽  
Toshifumi Kamiura ◽  
Katsuhiro Iba ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Multiple Endpoints ◽  
Industry Survey

Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan

2020 ◽  
Vol 54 (5) ◽  
pp. 1097-1105
Author(s):  
Kentaro Sakamaki ◽  
Yusuke Morita ◽  
Katsuhiro Iba ◽  
Toshifumi Kamiura ◽  
Seitaro Yoshida ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Sample Size Calculation ◽  
Multiple Endpoints ◽  
Industry Survey ◽  
Current Practices

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.

17A Bayesian designs for clinical trials with multiple endpoints

1994 ◽  
Vol 15 (3) ◽  
pp. 43
Author(s):  
Peter F. Thall ◽  
Richard M. Simon ◽  
Elihu H. Estey
Keyword(s):  
Clinical Trials ◽  
Multiple Endpoints ◽  
Bayesian Designs

scholarly journals A New Procedure of One-Sided Test in Clinical Trials with Multiple Endpoints

2014 ◽  
Vol 35 (1) ◽  
pp. 17-35
Author(s):  
Yoshiomi Nakazuru ◽  
Takashi Sozu ◽  
Chikuma Hamada ◽  
Isao Yoshimura
Keyword(s):  
Clinical Trials ◽  
Multiple Endpoints
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