Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring-Reference-Cited by-同舟云学术

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Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring

Published:2023-04-18 Issue:1 Volume:16 Page:130-139
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Zhang Xuekui¹^ORCID,Jia Haijun¹,Xing Li²,Chen Cong³

Affiliation:

1. Department of Mathematics and Statistics, University of Victoria, Victoria, Canada

2. Department of Mathematics and Statistics, University of Saskatchewan, Saskatoon, Canada

3. Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, NJ

Funder

Canada Research Chairs

Michael Smith Health Research BC

Natural Sciences and Engineering Research Council of Canada

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2023.2197402

Reference23 articles.

1. Applying CHW method to 2-in-1 design: gain or lose?

2. Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections by H. Schäfer and H.-H. Müller,Statistics in Medicine 2001;20: 3741–3751

3. A graphical approach to sequentially rejective multiple test procedures

4. A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development

5. Hypothesis Testing in a Confirmatory Phase III Trial With a Possible Subset Effect

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1. A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence;Journal of Cardiovascular Development and Disease;2024-06-21

2. A promising biomarker adaptive Phase 2/3 design – Explained and expanded;Contemporary Clinical Trials Communications;2023-12

3. Optimal trial design selection: a comparative analysis between two-arm and three-arm trials incorporating network meta-analysis for evaluating a new treatment;BMC Medical Research Methodology;2023-11-11

4. From bench to bedside, 2-in-1 design expedites phase 2/3 oncology drug development;Frontiers in Oncology;2023-10-09

5. A New Model Selection Metric for Biomarker Detection Algorithms and Tools;Journal of Mathematics;2023-07-08

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