A sequential enriched design for target patient population in psychiatric clinical trials-Reference-Cited by-同舟云学术

A sequential enriched design for target patient population in psychiatric clinical trials

Published:2014-02-20 Issue:17 Volume:33 Page:2953-2967
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Chen Yeh-Fong¹,Zhang Xiangmin²,Tamura Roy N.³,Chen Chiung M.⁴

Affiliation:

1. Division of Biometrics I, Office of Biostatistics; Office of Translational Sciences, Center of Drug Evaluation and Research (CDER), US Food and Drug Administration; Silver Spring MD U.S.A.

2. Department of Statistics and Actuarial Science; The University of Iowa; Iowa City IA U.S.A.

3. Pediatrics Epidemiology Center; University of South Florida; Tampa FL U.S.A.

4. CSR Incorporated; Arlington VA U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference19 articles.

1. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications;Khin;Journal of Clinical Psychiatry,2011

2. Exploratory analyses of efficacy data from schizophrenia trials in support of new drug application submitted to the US Food and Drug Administration;Khin;Journal of Clinical Psychiatry,2012

3. Innovations in clinical research design and conduct in psychiatry: shifting to pragmatic approaches;Marks;Psychiatry Investigation,2009

4. US Department of Health and Human Services Food and Drug Administration Guidance for industry: enrichment strategies for clinical trials to support approval of human drugs and biological products 2012 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf

5. Enrichment Design

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