Forward

Misrak Gezmu, C. Liang
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Abstract

Over the last three decades, statisticians and mathematical modelers have played a role in advancing the HIV/AIDS research byworking closelywith clinicians, experimentalists, subject matter area researchers and computer scientists. Their contributions include developingmathematical models to study the pathogenesis of the virus and to develop statistical methods for the design and analysis of HIV/AIDS therapeutics and vaccine clinical trials. This issue of Statistical Communication in Infectious Diseases contains papers from a workshop conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) on 23 March 2019 in Philadelphia, PA. The title of the workshop was “Statistical Challenges and Opportunities in HIV/AIDS Research in the Era of Getting-to-Zero HIV infections” The workshop was conducted as a pre-conference workshop at the Eastern North American Region (ENAR) of the International Biometric Society (IBS) 2019 conference. The purpose of the workshop was to bring together statisticians and subject matter area researchers working in HIV–AIDS research to: highlight current topics in HIV/AIDS Research with novel statistical challenges, to galvanize methodological research in priority areas in HIV–AIDS research and foster collaborations between statisticians in these priority areas, and to identify opportunities to strengthen collaborations internationally-particularly where input from statisticians may be most needed. The workshop participants were, mathematicians, statisticians, subject matter area researchers and computer scientists. At the end of the workshop, a panel discussion was conducted to encourage interaction between statisticians and subject matter area researchers. The discussion and the oral presentations showed that the advances in research will occur most productively when quantitative methods researchers are working in multidisciplinary teams with subject matter researchers and computer scientists. The eight papers in this issue cover a range of topics in HIV/AIDS research. Below are the summaries of the eight papers. Foulkes et al. demonstrate how leveraging prior information about the biological relationships among variables can increase power for novel discovery. They illustrated that application of a class-level testing strategy provides an alternative to single immune variables by defining hypotheses based on a collection of variables that share a known underlying biological relationship. Brown et al. propose joint modeling, along with the proposed empirical Bayes estimation approach that can provide valid estimation of the per-exposure efficacy of a preventive intervention. The proposed approach is illustrated with data from a simulation study and from the MTN-020/ASPIRE trial. Bing et al. compare empirical and dynamicmodels for HIV viral load rebound after treatment interruption. They apply and compare the two modeling approaches in analysis of data from 346 participants in six AIDS Clinical Trial Group studies. Although based on different sets of assumptions, they demonstrated that both models lead to similar conclusions regarding features of viral rebound process. Kimaina et al. compare machine learning techniques for predicting viral failure. Their goal is to use electronic health record data from a large HIV care program in Kenya to characterize and compare the
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在过去的三十年中,统计学家和数学建模者通过与临床医生、实验学家、主题领域研究人员和计算机科学家密切合作,在推进艾滋病毒/艾滋病研究方面发挥了作用。他们的贡献包括开发数学模型来研究病毒的发病机制,并开发用于设计和分析艾滋病毒/艾滋病治疗方法和疫苗临床试验的统计方法。本期《传染病统计传播》包含了2019年3月23日在宾夕法尼亚州费城由美国国立卫生研究院(NIH)国家过敏和传染病研究所(NIAID)举办的研讨会上的论文。研讨会的题目是“在实现零艾滋病毒感染的时代,艾滋病毒/艾滋病研究中的统计挑战和机遇”,该研讨会是作为国际生物识别学会(IBS) 2019年会议北美东部地区(ENAR)的会前研讨会进行的。讲习班的目的是使从事艾滋病毒/艾滋病研究的统计学家和专题领域的研究人员聚集在一起,以便:以新的统计挑战突出当前艾滋病毒/艾滋病研究中的主题,激励艾滋病毒/艾滋病研究优先领域的方法学研究,促进这些优先领域统计学家之间的合作,并确定加强国际合作的机会-特别是在最需要统计学家投入的地方。讲习班的参加者有数学家、统计学家、主题领域研究人员和计算机科学家。在讲习班结束时,进行了一次小组讨论,以鼓励统计学家和主题领域研究人员之间的互动。讨论和口头报告表明,当定量方法研究人员与主题研究人员和计算机科学家在多学科团队中合作时,研究的进展将最富有成效。本期的八篇论文涵盖了艾滋病毒/艾滋病研究的一系列主题。以下是八篇论文的摘要。Foulkes等人展示了如何利用关于变量之间生物关系的先验信息来增加新发现的力量。他们说明,类水平测试策略的应用提供了单一免疫变量的替代方案,通过定义基于共享已知潜在生物学关系的变量集合的假设。Brown等人提出了联合建模,并提出了经验贝叶斯估计方法,该方法可以有效地估计预防干预的每次暴露效果。通过模拟研究和MTN-020/ASPIRE试验的数据说明了所提出的方法。Bing等人比较了治疗中断后HIV病毒载量反弹的经验模型和动态模型。他们应用并比较了这两种建模方法,分析了来自6个艾滋病临床试验组研究的346名参与者的数据。尽管基于不同的假设,但他们证明,两种模型都得出了关于病毒反弹过程特征的相似结论。Kimaina等人比较了预测病毒失败的机器学习技术。他们的目标是利用肯尼亚一个大型艾滋病毒护理项目的电子健康记录数据来描述和比较这些项目
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Study design approaches for future active-controlled HIV prevention trials. The role of randomization inference in unraveling individual treatment effects in early phase vaccine trials. Nonlinear mixed-effects models for HIV viral load trajectories before and after antiretroviral therapy interruption, incorporating left censoring. Estimation and interpretation of vaccine efficacy in COVID-19 randomized clinical trials Sample size calculation for active-arm trial with counterfactual incidence based on recency assay.
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