设计新一代艾滋病预防疗效试验:2018年学术研讨会纪要

H. Janes, D. Donnell, M. Nason
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引用次数: 1

摘要

2018年11月5日,一场为期一天的研讨会在华盛顿西雅图举行,参会人员包括艾滋病预防界的广泛利益相关者。鉴于近年来该领域变化的多样性和速度,有效预防工具的开发和推出,以及设计评估新的艾滋病毒预防产品的试验的复杂性,讨论的主题是设计未来艾滋病毒预防功效试验所面临的挑战。目的是确定值得进一步调查的潜在统计试验设计方法,以及理解和逻辑下一步的差距。我们概述了从演示、小组讨论和现场讨论中出现的主题,并概述了进一步探索设计选项的初步下一步。
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Designing the Next Generation of HIV Prevention Efficacy Trials: Synopsis of a 2018 Symposium
Abstract A one-day symposium was held in Seattle, Washington on November 5, 2018, including a broad array of stakeholders in the HIV prevention community. The topic of discussion was the challenge of designing future HIV prevention efficacy trials, given the multiplicity and speed of changes in the field in recent years, the development and rollout of effective prevention tools, and the resultant complexity in designing trials to evaluate new HIV prevention products. The goal was to identify potential statistical trial design approaches worthy of further investigation, as well as gaps in understanding and logical next steps. We overview the themes that emerged from the presentations, panels, and floor discussions, and outline initial next steps in further exploring design options.
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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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