Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate-Reference-Cited by-同舟云学术

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Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate

Published:2015-11-17 Issue:4 Volume:26 Page:672-685
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Weng Yanqiu¹,Palesch Yuko Y.²,DeSantis Stacia M.³,Zhao Wenle²

Affiliation:

1. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

2. Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA

3. Division of Biostatistics, School of Public Health, University of Texas Health Sciences Center, Houston, Texas, USA

Funder

National Institute of Neurological Disorders and Stroke

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2015.1052473

Reference26 articles.

1. Repeated Significance Tests on Accumulating Data

2. Formal approaches to safety monitoring of clinical trials in life-threatening conditions

3. Coupled Error Spending Functions for Parallel Bivariate Sequential Tests

4. Guidelines for Monitoring Efficacy and Toxicity Responses in Clinical Trials

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