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Comparing the Survival of Two Groups with an Intermediate Clinical Event

Authors
 Chung Mo Nam  ;  Marvin Zelen 
Citation
 LIFETIME DATA ANALYSIS, Vol.7(1) : 5-19, 2001 
Journal Title
 LIFETIME DATA ANALYSIS 
ISSN
 1380-7870 
Issue Date
2001
MeSH
AIDS-Related Opportunistic Infections/complications ; AIDS-Related Opportunistic Infections/drug therapy ; Acquired Immunodeficiency Syndrome/complications ; Acquired Immunodeficiency Syndrome/drug therapy ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/therapeutic use ; Antibiotic Prophylaxis ; Computer Simulation ; Dose-Response Relationship, Drug ; HIV-1 ; Humans ; Markov Chains ; Models, Statistical* ; Pneumocystis ; Pneumonia, Pneumocystis/complications ; Pneumonia, Pneumocystis/drug therapy ; Randomized Controlled Trials as Topic/methods* ; Survival Analysis* ; Zidovudine/administration & dosage ; Zidovudine/therapeutic use
Keywords
clinical trials ; intermediate events ; semi-Markov processes ; score tests ; zidovudine
Abstract
Consider a subject entered on a clinicaltrial in which the major endpoint is a time metric such as deathor time to reach a well defined event. During the observationalperiod the subject may experience an intermediate clinical event.The intermediate clinical event may induce a change in the survivaldistribution. We consider models for the one and two sample problem.The model for the one sample problem enables one to test if theoccurrence of the intermediate event changed the survival distribution.This models provides a way of carrying out non-randomized clinicaltrial to determine if a therapy has benefit. The two sample problemconsiders testing if the probability distributions, with andwithout an intermediate event, are the same. Statistical testsare derived using a semi-Markov or a time dependent mixture model.Simulation studies are carried out to compare these new procedureswith the log rank, stratified log rank and landmark tests. Thenew tests appear to have uniformly greater power than these competitortests. The methods are applied to a randomized clinical trialcarried out by the Aids Clinical Trial Group (ACTG) which comparedlow versus high doses of zidovudine (AZT).
Full Text
http://link.springer.com/article/10.1023/A%3A1009609925212
DOI
10.1023/A:1009609925212
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Preventive Medicine and Public Health (예방의학교실) > 1. Journal Papers
Yonsei Authors
Nam, Chung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/142669
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