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Composite Endpoint Study Of Recurrent And Terminal Event

Posted on:2022-12-08Degree:MasterType:Thesis
Country:ChinaCandidate:Y H ZhangFull Text:PDF
GTID:2480306773493254Subject:Pharmaceutics
Abstract/Summary:PDF Full Text Request
In clinical trial research,a recurrent event refers to the repeated experience of a particular individual by certain events.These events may or may not be of the same type.For example,many patients with chronic cardiovascular disease suffer from repeated hospitalizations due to heart failure(recurrent event 1)or myocardial infarction(recurrent event 2).In order to measure the therapeutic effect of drugs,the traditional method that only considers the occurrence time of the first event will cause a certain deviation due to ignoring the subsequent recurrence events.Considering the correlation between relapse events and between relapse events and death,this paper firstly established a multivariate joint fragility model to measure the effect of drug treatment by estimating regression coefficients,variance and correlation coefficients.However,because it is more desirable to use a comprehensive expression to measure drug efficacy in actual clinical research,this paper establishes a data-driven weighted model.Compared with the multivariate joint fragility model,the data-driven weighted model is more convenient to test in clinical trials because all relapse events and deaths are taken into account in one expression.In order to verify the effectiveness of the method,this paper applies these two methods to a clinical trial study,which mainly studies the effectiveness and safety of an innovative drug for cardiovascular disease.There was some reduction in the risk of hospitalization and risk of death,suggesting that drug therapy was effective.In addition,the data-driven weighted composite model established in this paper also has better effect than the previous methods of subjectively determining weights.
Keywords/Search Tags:clinical trials, recurrent events, composite endpoints, joint fragility model, data-driven weighted model
PDF Full Text Request
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