Addressing Multiplicity Issues of a Composite Endpoint and Its Components in Clinical Trials-Reference-Cited by-同舟云学术

Addressing Multiplicity Issues of a Composite Endpoint and Its Components in Clinical Trials

Published:2011-04-22 Issue:4 Volume:21 Page:610-634
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Huque Mohammad F.¹,Alosh Mohamed²,Bhore Rafia³

Affiliation:

1. a Division of Biometrics IV, Office of Biostatistics , OTS, CDER/FDA , Silver Spring, Maryland, USA

2. b Division of Biometrics III, Office of Biostatistics , OTS, CDER/FDA , Silver Spring, Maryland, USA

3. c Division of Biostatistics, Department of Clinical Sciences , University of Texas, Southwestern Medical Center , Dallas, Texas, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2011.551327

Reference21 articles.

1. A flexible strategy for testing subgroups and overall population

2. Committee for Proprietary Medicinal Products . ( 2002 ).Points to consider on multiplicity issues in clinical trials.CPMP/EWP/908/99. http://www.emea.eu.int/pdfs/human/ ewp/090899en.pdf

3. A graphical approach to sequentially rejective multiple test procedures

4. Some issues with composite endpoints in clinical trials

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