Novel Methods to Inform HIV/TB Clinical Trial Development

为 HIV/TB 临床试验开发提供信息的新方法

• 批准号: 10203771
• 负责人: Krishna P Reddy
• 金额: $ 80.47万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10203771
• 关键词: Accounting; Acquired Immunodeficiency Syndrome; Area; Cause of Death; Clinical Trials; Clinical Trials Design; Collaborations; Costs and Benefits; Development; Evaluation; HIV/TB; Instruction; International; Mediating; Methodology; Methods; Modeling; Monte Carlo Method; Prevention; Productivity; Reporting; Resources; Sampling; Science; South Africa; antiretroviral therapy; cost effectiveness; design; development policy; information framework; low income country; novel; prevent; treatment strategy; tuberculosis diagnostics; vaccination strategy; vaccine-induced antibodies

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.

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 使用了决策科学方法，注重信息的价值，并证明了 杰出的生产力，方法扩展，培训生发展，政策影响，以及国际 协作当我们完成这个周期并期待下一个周期时，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， 具体目标如下： 1)利用广义加性模型计算样本信息期望值 在预防艾滋病并发症的成本效益的蒙特卡罗模拟中， （CEPAC）模型。 2)扩展目标1中开发的方法，以告知新的临床试验设计，试验后 在南非艾滋病毒和结核病领域进行评估和确定优先事项，重点关注新报告的 潜在的高影响力试验我们将重点关注三个方面： I.抗逆转录病毒治疗策略 二.疫苗和抗体介导的预防 三.新型结核病诊断、治疗和疫苗接种策略 我们预计下一个R37周期将继续保持高生产率，为决策者提供高效的信息。 在实施已经实施的试验结果和开展 那些正在设计的。 相关性（参见说明）： 艾滋病毒和结核病仍然是低收入国家十大死亡原因之一。鉴于预算 限制进行一系列正在进行的和潜在的临床试验，我们已经制定了一个价值， 信息（VOI）框架，以评估先验哪些试验可能提供最佳价值，正式 在有和没有新信息的情况下（如可能从试验中获得的信息）比较行动方案， 量化信息获取的价值，同时考虑试验的收益和成本。