Use of a historical control group in a noninferiority trial assessing a new antibacterial treatment: A case study and discussion of practical implementation aspects-Reference-Cited by-同舟云学术

Use of a historical control group in a noninferiority trial assessing a new antibacterial treatment: A case study and discussion of practical implementation aspects

Published:2017-12-28 Issue:2 Volume:17 Page:169-181
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Dejardin David¹^ORCID,Delmar Paul¹,Warne Charles²,Patel Katie²,van Rosmalen Joost³,Lesaffre Emmanuel⁴

Affiliation:

1. Department of Biostatistics; F. Hoffmann-La Roche; Basel Switzerland

2. Department of Biostatistics; Roche Products Ltd; Welwyn Garden City UK

3. Department of Biostatistics; Erasmus University Medical Center; Rotterdam the Netherlands

4. Interuniversity Institute for Biostatistics and Statistical Bioinformatics; KU Leuven; Leuven Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference18 articles.

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2. Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products;Gamalo;Pharm Stat,2014

3. FDA Antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases http://www.fda.gov/cder/guidance/index.htm 2013

4. The inclusion of historical control data may reduce the power of a confirmatory study;Cuffe;Stat Med,2011

5. Use of historical control data for assessing treatment effects in clinical trials;Viele;Pharm Stat,2014

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