Research article summary (published 13 Dec 2004):

Score tests for dose effect in the presence of non-responders.

Full Abstract

When only a certain proportion of subjects respond to treatment ('responders') or may never experience an event of interest (thus 'cured'), mixture models often lead to increased understanding of the treatment or disease process. This paper focuses on hypothesis testing in a dose-response framework and shows that increased power is possible by using a mixture model where both the logit of the response rate and the response mean are linear functions of the dose level. Three score tests are developed for testing an overall effect and permutation methods are used to control the type I error. Extensive simulations establish the power properties of the tests and show that our proposed score test has the best performance. The approach is illustrated by a multi-country clinical trial of rapid acting Intramuscular Olanzapine. Copyright 2004 John Wiley & Sons, Ltd.

Author information

Author/s: Luo, Xiaohui (X); Boos, Dennis D (DD); Tamura, Roy N (RN);

Affiliation: Department of Statistics, North Carolina State University, Raleigh, NC 27695-8203, USA. edmund_luo(-atsign-)merck.com

Journal and publication information

Publication Type: Journal Article

Journal: Statistics in medicine (Stat Med), published in England. (Language: eng)

Reference: 2004-Dec; vol 23 (issue 23) : pp 3581-91

Dates: Created 2004/12/03; Completed 2005/03/07; Revised 2008/11/21;

PMID: 15534896, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Algorithms Benzodiazepines - administration & dosage Biometry - methods Clinical Trials as Topic - statistics & numerical data Dose-Response Relationship, Drug Humans Injections, Intramuscular

Likelihood Functions Linear Models Models, Statistical Monte Carlo Method Pharmaceutical Preparations - administration & dosage Psychomotor Agitation - drug therapy Schizophrenia - drug therapy

Associated Chemicals: Pharmaceutical Preparations (0) ; Benzodiazepines (12794-10-4) ; olanzapine (132539-06-1)

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