Correcting for non-compliance in randomized non-inferiority trials with active and placebo control using structural models-Reference-Cited by-同舟云学术

Correcting for non-compliance in randomized non-inferiority trials with active and placebo control using structural models

Published:2014-12-23 Issue:6 Volume:34 Page:950-965
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Wu Ying¹,Zhao Liang¹,Hou Yan¹,Li Kang¹,Zhou Xiaohua²

Affiliation:

1. Department of Epidemiology and Biostatistics, Public Health College; Harbin Medical University; Harbin 150081 Heilongjiang China

2. Department of Biostatistics, School of Public Health and Community Medicine; University of Washington; Seattle 98195 WA U.S.A.

Funder

National Natural Science Foundation of China

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/sim.6392/fullpdf

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4. FDA (Food and Drug Administration) Guidance for industry on non-inferiority clinical trials, 2010 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf

5. Committee for Proprietary Medicinal Products Points to consider on application with 1. Meta-Analyses; 2. One Pivotal Study, 2001 http://www.emea.europa.eu/pdfs/human/ewp/233099fen.pdf

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