Document Detail


Group sequential designs for monitoring survival probabilities.
MedLine Citation:
PMID:  8805766     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In the present paper we derive the asymptotic joint distribution of the Nelson-Aalen estimators for the cumulative hazard function (or the Kaplan-Meier estimators for the survival function) calculated at different (possibly random) calendar time points of a survival study. This result is used to develop group sequential designs for clinical trials in which patients are enrolled over an extended period and the survival probability at a given failure time point is the parameter of primary interest. The proposed designs allow monitoring the survival probability (or probabilities) at interim looks so that the study can be terminated when there is sufficient evidence for a positive or negative result. A detailed illustration is provided with a problem from the National Wilms Tumor Study Group, which motivated this research.
Authors:
D Y Lin; L Shen; Z Ying; N E Breslow
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Biometrics     Volume:  52     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1996-11-06     Completed Date:  1996-11-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1033-41     Citation Subset:  IM    
Affiliation:
Department of Biostatistics, University of Washington, Seattle 98195, USA.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Biometry
Child
Child, Preschool
Clinical Protocols
Clinical Trials as Topic / statistics & numerical data*
Combined Modality Therapy
Data Interpretation, Statistical
Humans
Infant
Kidney Neoplasms / drug therapy,  mortality,  surgery
Probability
Survival Analysis*
Wilms Tumor / drug therapy,  mortality,  surgery
Grant Support
ID/Acronym/Agency:
AI-291968/AI/NIAID NIH HHS; CA-42326/CA/NCI NIH HHS; GM-47845/GM/NIGMS NIH HHS

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


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