Simultaneous population enrichment and endpoint selection in phase 3 randomized controlled trials: An adaptive group sequential design with two binary alternative primary endpoints-Reference-Cited by-同舟云学术

Simultaneous population enrichment and endpoint selection in phase 3 randomized controlled trials: An adaptive group sequential design with two binary alternative primary endpoints

Published:2023-01-03 Issue: Volume: Page:1-14
ISSN:0361-0926
Container-title:Communications in Statistics - Theory and Methods
language:en
Short-container-title:Communications in Statistics - Theory and Methods

Author:

Sinha Arup K.¹,Moye Lemuel¹,Piller Linda B.²,Yamal Jose-Miguel¹,Barcenas Carlos H.³,Song Jaejoon⁴,Davis Barry R.¹

Affiliation:

1. Department of Biostatistics, The University of Texas School of Public Health, Houston, Texas, USA

2. Division of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas School of Public Health, Houston, Texas, USA

3. Department of Breast Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA

4. Department of Biostatistics, MD Anderson Cancer Center, Houston, Texas, USA

Publisher

Informa UK Limited

Subject

Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/03610926.2022.2163180

Reference26 articles.

1. Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints

2. Primary End Points in Phase III Clinical Trials of Severe Head Trauma: DRS Versus GOS

3. Coupled Error Spending Functions for Parallel Bivariate Sequential Tests

4. Introduction to Statistical Methods for Clinical Trials

5. Innovation in the pharmaceutical industry: New estimates of R&D costs

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