Document Detail

Power considerations for clinical trials using multivariate time-to-event data.
MedLine Citation:
PMID:  9160485     Owner:  NLM     Status:  MEDLINE    
Many clinical trials involve the collection of data on the times to occurrence of different types of events, such as different fungal infections in AIDS research, or of recurrences of the same type, such as successive fits in epilepsy research. The multivariate proportional hazards model allows for analysis of this data and software for doing this is now widely available. In this paper, the approximate power of a clinical trial that aims to use such data for comparing two treatments is derived. Special attention is given to the bivariate case, both to show that the approximation works well and to illustrate how various design parameters affect the power of a trial. As with any multivariate data in clinical trials, there are many conceptual issues that should be considered during trial design; the paper closes with a discussion of some of these.
M D Hughes
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Statistics in medicine     Volume:  16     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1997 Apr 
Date Detail:
Created Date:  1997-07-17     Completed Date:  1997-07-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  865-82     Citation Subset:  IM; X    
Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA.
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MeSH Terms
AIDS-Related Opportunistic Infections
Clinical Trials as Topic / methods*
Models, Statistical
Multivariate Analysis*
Proportional Hazards Models*
Research Design
Sampling Studies
Time Factors
Grant Support

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