Testing multiple primary endpoints in clinical trials with sample size adaptation

2015 ◽  
Vol 15 (1) ◽  
pp. 37-45
Author(s):  
Yi Liu ◽  
Mingxiu Hu
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Primary Endpoints ◽  
Multiple Primary

scholarly journals Statistical Issues in Clinical Trials with Multiple Primary Endpoints

2013 ◽  
Vol 34 (1) ◽  
pp. 35-52
Author(s):  
Takashi Sozu ◽  
Tomoyuki Sugimoto ◽  
Toshimitsu Hamasaki
Keyword(s):  
Clinical Trials ◽  
Primary Endpoints ◽  
Multiple Primary ◽  
Statistical Issues

scholarly journals Sample size determination in group-sequential clinical trials with two co-primary endpoints

2014 ◽  
Vol 33 (17) ◽  
pp. 2897-2913 ◽  
Author(s):  
Koko Asakura ◽  
Toshimitsu Hamasaki ◽  
Tomoyuki Sugimoto ◽  
Kenichi Hayashi ◽  
Scott R. Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Sample Size Determination ◽  
Size Determination ◽  
Group Sequential ◽  
Primary Endpoints

Power and Sample Size Determination in Clinical Trials with Multiple Primary Continuous Correlated Endpoints

2014 ◽  
Vol 24 (2) ◽  
pp. 378-397 ◽  
Author(s):  
Pierre Lafaye de Micheaux ◽  
Benoit Liquet ◽  
Sébastien Marque ◽  
Jérémie Riou
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Sample Size Determination ◽  
Size Determination ◽  
Multiple Primary

Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints

Biometrics ◽  
2004 ◽  
Vol 60 (1) ◽  
pp. 134-145 ◽  
Author(s):  
Michael R. Kosorok ◽  
Shi Yuanjun ◽  
David L. DeMets
Keyword(s):  
Clinical Trials ◽  
Group Sequential ◽  
Primary Endpoints ◽  
Multiple Primary

scholarly journals Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints

PLoS ONE ◽  
2017 ◽  
Vol 12 (6) ◽  
pp. e0180405 ◽  
Author(s):  
Wong-Shian Huang ◽  
Hui-Nien Hung ◽  
Toshimitsu Hamasaki ◽  
Chin-Fu Hsiao
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Specific Region ◽  
Sample Size Determination ◽  
Size Determination ◽  
Primary Endpoints

scholarly journals A Test for Multiple Binary Endpoints with Continuous Latent Distribution in Clinical Trials

2021 ◽  
Vol 20 (4) ◽  
pp. 463-480
Author(s):  
Takuma Ishihara ◽  
Kouji Yamamoto
Keyword(s):  
Clinical Trials ◽  
Latent Variables ◽  
Testing Procedure ◽  
Association Measure ◽  
Binary Responses ◽  
Testing Procedures ◽  
Primary Endpoints ◽  
Latent Distribution ◽  
Multiple Primary ◽  
Continuous Responses

AbstractIn clinical trials, two or more binary responses obtained by dichotomizing continuous responses are often employed as multiple primary endpoints. Testing procedures for multiple binary variables with latent distribution have not yet been adequately discussed. Based on the association measure among latent variables, we provide a statistic for testing the superiority of at least one binary endpoint. In addition, we propose a testing procedure with a framework in which the trial efficacy is confirmed only when there is superiority of at least one endpoint and non-inferiority of the remaining endpoints. The performance of the proposed procedure is evaluated through simulations.

scholarly journals Appealing for Efficient, Well Organized Clinical Trials on COVID-19

2020 ◽  
Author(s):  
Yang Zhao ◽  
Yongyue Wei ◽  
Sipeng Shen ◽  
Mingzhi Zhang ◽  
Feng Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Scientific Community ◽  
Treatment Modalities ◽  
Biological Therapies ◽  
Clinical Trial Registration ◽  
Stage Design ◽  
Primary Endpoints ◽  
Rapid Emergence

ABSTRATCThe rapid emergence of clinical trials on COVID-19 stimulated a wave of discussion in scientific community. We reviewed the characteristics of interventional trials from Chinese Clinical Trial Registration (ChiCTR) and ClinicalTrials.gov. A total of 171 COVID-19-related interventional trials were identified on Feb 22nd, 2020. These trials are classified into 4 categories based on treatment modalities, including chemical drugs, biological therapies, traditional Chinese medicine treatments and other therapies. Our analysis focused on the issues of stage, design, randomization, blinding, primary endpoints definition and sample size of these trials. We found some studies with potential defects including unreasonable design, inappropriate primary endpoint definition, insufficient sample size and ethical issue. Clinical trials on COVID-19 should be designed based on scientific rules, ethics and benefits for patients.

Reducing unnecessary measurements in clinical trials with multiple primary endpoints

2016 ◽  
Vol 26 (4) ◽  
pp. 631-643 ◽  
Author(s):  
Takashi Sozu ◽  
Tomoyuki Sugimoto ◽  
Toshimitsu Hamasaki
Keyword(s):  
Clinical Trials ◽  
Primary Endpoints ◽  
Multiple Primary
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