A reproducibility probability-based bias-adjustment approach on the specification of non-inferiority margin using historical data-Reference-Cited by-同舟云学术

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A reproducibility probability-based bias-adjustment approach on the specification of non-inferiority margin using historical data

Published:2019-06-19 Issue:6 Volume:29 Page:990-1002
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Yu Yongpei¹²,Yan Xiaoyan²,Song Fuyu³,Yao Chen²,Xia Jielai¹

Affiliation:

1. Department of Health Statistics, College of Military Preventive Medicine, the Fourth Military Medical University, Xi’an, Shaanxi, China

2. Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China

3. Center for Food and Drug Inspection of CFDA, Beijing, China

Funder

National Major Scientific and Technological Special Project of China for “Significant New Drugs Development”

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2019.1632879

Reference26 articles.

1. Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials

2. Defining the noninferiority margin and analysing noninferiority: An overview

3. Operating Characteristics of a Rank Correlation Test for Publication Bias

4. Some methodological points to consider when performing systematic reviews in comparative effectiveness research

5. Showing a treatment is good because it is not bad

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The use of real-world data/evidence in regulatory submissions;Contemporary Clinical Trials;2021-10

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