Document Detail


Statistical methods for the analysis of relapse data in MS clinical trials.
MedLine Citation:
PMID:  19709676     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Patients with multiple sclerosis (MS) often experience unpredictable recurrent relapses with periods of remission. The modeling of MS relapse data is complicated because both within-subject serial dependence between relapses and between-patient heterogeneity may exist. We compare six statistical methods for assessing the treatment efficacy in reducing the frequency of relapses in MS clinical trials. All methods can be implemented in SAS, and are grouped into two classes, one based on Poisson-type regressions for count data and the other on Cox proportional hazards models for time to relapse. We apply these models to the data of a Tysabri (Natalizumab) MS trial and interpret the differences in results based on the underlying assumptions. Negative binomial regression is recommended for evaluating the overall treatment effect because of its simplicity and efficiency.
Authors:
Y C Wang; L Meyerson; Y Q Tang; N Qian
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2009-08-25
Journal Detail:
Title:  Journal of the neurological sciences     Volume:  285     ISSN:  1878-5883     ISO Abbreviation:  J. Neurol. Sci.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-09-09     Completed Date:  2010-01-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375403     Medline TA:  J Neurol Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  206-11     Citation Subset:  IM    
Affiliation:
Department of Biometrics, Biogen Idec, 14 Cambridge Center, Cambridge, MA 02142, USA. yong-cheng.wang@biogenidec.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Antibodies, Monoclonal / therapeutic use
Binomial Distribution
Biomedical Research / methods*
Clinical Trials as Topic
Computers
Female
Humans
Immunologic Factors / therapeutic use
Male
Models, Statistical*
Multiple Sclerosis / drug therapy,  therapy*
Poisson Distribution
Proportional Hazards Models
Recurrence
Regression Analysis
Software
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Immunologic Factors; 0/natalizumab

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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