Regulatory Guidance on Randomization and the Use of Randomization Tests in Clinical Trials: A Systematic Review-Reference-Cited by-同舟云学术

Regulatory Guidance on Randomization and the Use of Randomization Tests in Clinical Trials: A Systematic Review

Published:2023-08-15 Issue: Volume: Page:1-13
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Carter Kerstine¹^ORCID,Scheffold Annika L.²,Renteria Jone³^ORCID,Berger Vance W.⁴,Luo Yuqun Abigail⁵,Chipman Jonathan J.⁶^ORCID,Sverdlov Oleksandr⁷^ORCID

Affiliation:

1. Therapeutic Area and Methodology Statistics, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT

2. Therapeutic and Methodology Statistics, Boehringer Ingelheim Pharma GmbH und Co KG, Biberach, Germany

3. Department of Biostatistics and Bioinformatics, The George Washington University Milken Institute of Public Health, Washington, DC

4. National Cancer Institute, Rockville, MD

5. US Food and Drug Administration, Silver Spring, MD

6. Huntsman Cancer Institute, University of Utah, University of Utah Health, Salt Lake City, UT

7. Early Development Analytics, Novartis Pharmaceuticals Corporation, East Hanover, NJ

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2023.2239521

Reference43 articles.

1. Pros and cons of permutation tests in clinical trials

2. ——- (2018), “The Alleged Benefits of Unrestricted Randomization,” in Randomization, Masking, and Allocation Concealment, ed. V. W. Berger, pp. 39–49, Boca Raton, FL: CRC Press.

3. A roadmap to using randomization in clinical trials

4. Minimizing predictability while retaining balance through the use of less restrictive randomization procedures

5. Minimization—reducing predictability for multi-centre trials whilst retaining balance within centre

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