Assessing consistency in clinical trials with two subgroups and binary endpoints: A new test within the logistic regression model-Reference-Cited by-同舟云学术

Assessing consistency in clinical trials with two subgroups and binary endpoints: A new test within the logistic regression model

Published:2020-10-26 Issue:30 Volume:39 Page:4551-4573
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Grill Susann¹²,Ring Arne³⁴,Brannath Werner²^ORCID,Scharpenberg Martin²^ORCID

Affiliation:

1. Department Biometry and Data Management Leibniz Institute for Prevention Research and Epidemiology – BIPS GmbH Bremen Germany

2. Competence Center for Clinical Trials Bremen University of Bremen Bremen Germany

3. medac GmbH Wedel Germany

4. Department of Mathematical Statistics and Actuarial Science University of the Free State Bloemfontein South Africa

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.8719

Reference29 articles.

1. European Medicines Agency: EMA/CHMP/539146/2013 ‐ Guideline on the investigation of subgroups in confirmatory clinical trials;2019.https://www.ema.europa.eu/en/documents/scientific‐guideline/guideline‐investigation‐subgroups‐confirmatory‐clinical‐trials_en.pdf. Assessed January 28 2020.

2. Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

3. A statistical framework for decision making in confirmatory multipopulation tailoring clinical trials;Millen BA;Ther Innov Regul Sci,2012

4. General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials

5. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives

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