Novel Methods to Inform HIV/TB Clinical Trial Development

在R37周期的前3.5年，为HIV/TB临床试验开发提供信息的新方法 使用决策科学方法，专注于信息的价值，并展示了 卓越的工作效率、方法扩展、学员发展、政策影响和国际化 协作。随着我们完成这个周期并期待下一个周期，我们将继续 开发和利用新的VOI方法，将其应用于正在进行的和新的国际试验活动 以下是具体目标： 1)使用广义加性模型计算样本信息的期望值(ESVI (GAMS)内蒙特卡罗模拟预防艾滋病并发症的成本效益 (CEPAC)模式。 2)扩展目标1中开发的方法，以通知新的临床试验设计、试验后 评价和确定南非艾滋病毒和结核病领域的优先事项，重点是新报告的和 潜在的高影响试验。我们将重点抓好三个方面： 一、抗逆转录病毒治疗策略 二、疫苗和抗体介导的预防 三、新的结核病诊断、治疗和疫苗接种策略 我们预计下一个R37周期将继续提高生产率，向决策者提供有关高效 在执行已完成的试验结果时和在进行 那些正在设计的。 相关性(请参阅说明)： 艾滋病毒和结核病在低收入国家的十大死因中仍然居高不下。考虑到预算 进行一系列正在进行的和潜在的临床试验的限制条件下，我们开发了 正式评估哪些试验可能提供最佳价值的先验信息(VOI)框架 将有和没有新信息的行动方案--可以从审判中获得--进行比较 量化信息获取的价值，同时考虑试验收益和成本。

During the first 3.5 years of this R37 cycle, Novel Methods to Inform HIV/TB Clinical Trial Development has used decision science methodologies, focusing on value of information, and demonstrated outstanding productivity, methods expansion, trainee development, policy impact, and international collaboration. As we complete this cycle and look forward to the subsequent one, we will continue to develop and utilize novel VOI methods, applying them to ongoing and new international trial activities with the following specific aims: 1) To calculate the expected value of sample information (ESVI) using generalized additive models (GAMs) within the Monte Carlo simulation of the Cost-effectiveness of Preventing AIDS Complications (CEPAC) model. 2) To expand upon the methods developed in Aim 1 to inform new clinical trial design, post-trial evaluation, and priority setting in the areas of HIV and TB in South Africa, focusing on newly reported and potential high-impact trials. We will focus on three areas: i. Antiretroviral Treatment Strategies ii. Vaccines and Antibody-Mediated Prevention iii. Novel Tuberculosis Diagnostic, Treatment, and Vaccination Strategies We anticipate continued major productivity in the next R37 cycle, informing decision makers on efficient use of resources both in the implementation of trial results once already performed and in the conduct of those being designed. RELEVANCE (See instructions): HIV and TB remain high among the top ten causes of death in low-income countries. Given the budgetary constraints to conduct the array of ongoing and potential clinical trials, we have developed a Value of Information (VOI) framework to assess a priori which trials might provide the best value, formally comparing courses of action with and without new information – as might be obtained from a trial – to quantify the value of information acquisition, accounting for both the trial benefits and costs.