Statistical Methods in HIV/AIDS Research

描述(由申请人提供)：艾滋病毒/艾滋病研究项目摘要中的统计方法本方法提案的目的是开发和应用新的统计方法，以改进对艾滋病毒/艾滋病研究中收集的数据的科学推断，具体目的是：(1)开发一类通用的回归模型，以研究艾滋病毒治疗和预防疗效试验中的剩余时间。所开发的方法将被应用于在剩余时间内确定早期和延迟的抗逆转录病毒疗法启动对于患者定义艾滋病疾病或死亡的时间是否重要，并进一步探索在抗逆转录病毒治疗启动后进展为艾滋病或死亡的重要临床因素；(2)开发复发事件和标记过程数据的统计方法，这些数据显示在信息性失败事件之前的终末行为。开发的方法将用于检查治疗方案与机会性感染等复发事件的完整历史之间的相关性，同时考虑到临床医生在常规护理过程中可用的变量；(3)开发统计方法，从随机艾滋病毒预防试验中复杂的纵向数据推断因果治疗效果。 公共卫生相关性：艾滋病毒/艾滋病研究项目中的统计方法本提案旨在发展艾滋病毒/艾滋病研究中的统计方法。具体地说，这些方法的目标是在复杂的艾滋病毒/艾滋病临床试验中对被审查的剩余寿命进行回归分析，在存在终末事件的情况下分析反复出现的标志物，以及对治疗效果进行信息性审查和因果推断。在项目成功完成后，拟议的方法将为艾滋病毒/艾滋病研究的资源规划、临床咨询和疗效评估提供一套新的统计工具。

DESCRIPTION (provided by applicant): Statistical Methods in HIV/AIDS Research Project Summary The objective of this methods proposal is to develop and apply new statistical methods to improve scientific inferences for data collected in HIV/AIDS research, specifically aiming to: (1) develop a general class of regression models to study residual time in HIV treatment and prevention efficacy trials. The developed methods will be applied to determine in residual time whether early versus delayed ART initiation is important in patient's time to AIDS-defining illness or death, and to further explore the clinical factors which are important in governing the progression to AIDS or death after ART initiation; (2) develop statistical methods for recurrent event and marker process data that exhibit a terminal behavior before an informative failure event. The developed methods will be applied to examine the correlation between treatment regimens and the complete history of recurrent events such as opportunistic infections, taking into account variables available to clinicians in the course of routine care; (3) develop statistical methodologies to infer causal treatment effect from complex longitudinal data in randomized HIV prevention trials. PUBLIC HEALTH RELEVANCE: Statistical Methods in HIV/AIDS Research Project Narrative This proposal aims to develop statistical methods in HIV/AIDS research. Specifically, these methods are targeted to regression analysis of censored residual life, analysis of recurrent markers in the presence of terminal events, and informative censoring and causal inferences of treatment efficacy in complex HIV/AIDS clinical trials. Upon successful completion of the project, the proposed methods shall provide a collection of new statistical tools for resource planning, clinical consulting and efficacy assessment in HIV/AIDS research.