Sample size determination in group-sequential clinical trials with two co-primary endpoints-Reference-Cited by-同舟云学术

Sample size determination in group-sequential clinical trials with two co-primary endpoints

Published:2014-03-27 Issue:17 Volume:33 Page:2897-2913
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Asakura Koko¹²,Hamasaki Toshimitsu¹²,Sugimoto Tomoyuki³,Hayashi Kenichi¹,Evans Scott R.⁴,Sozu Takashi⁵

Affiliation:

1. Department of Biomedical Statistics; Osaka University Graduate School of Medicine; Osaka Japan

2. Office of Biostatistics and Data Management, Research and Development Initiative Center; National Cerebral and Cardiovascular Center; Osaka Japan

3. Department of Mathematical Sciences; Graduate School of Science and Technology, Hirosaki University; Aomori Japan

4. Department of Biostatistics and the Center for Biostatistics in AIDS Research; Harvard School of Public Health; Boston MA U.S.A.

5. Department of Biostatistics; Kyoto University School of Public Health; Kyoto Japan

Funder

National Institute of Allergy and Infectious Diseases

Japan Society for the Promotion of Science

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference33 articles.

1. Committee for Medicinal Products for Human Use (CHMP) Guideline on Medicinal Products for the Treatment Alzheimer's Disease and Other Dementias (CPMP/EWP/553/95 Rev.1) 2008

2. Multiple co-primary endpoints: medical and statistical solutions;Offen;Drug Information Journal,2007

3. Some controversial multiple testing problems in regulatory applications;Hung;Journal of Biopharmaceutical Statistics,2009

4. Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial;Xiong;Clinical Trials,2005

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