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: 10474351
• 负责人: Krishna P Reddy
• 金额: $ 81.06万
• 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/10474351
• 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; diagnostic strategy; 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 年中，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，关注信息的价值，并证明 出色的生产力、方法扩展、学员发展、政策影响和国际化 合作。当我们完成这个周期并期待下一个周期时，我们将继续 开发和利用新颖的 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）使用广义加性模型计算样本信息的期望值（ESVI） (GAM) 蒙特卡罗模拟预防艾滋病并发症的成本效益 （CEPAC）模型。 2) 扩展目标 1 中开发的方法，为新的临床试验设计、试验后提供信息 南非艾滋病毒和结核病领域的评估和优先事项确定，重点是新报告和 潜在的高影响试验。我们将重点关注三个领域： 我。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 周期将继续保持主要生产力，从而为决策者提供高效的信息 在实施已经完成的试验结果和进行试验过程中使用资源 那些正在设计的。 相关性（参见说明）： 艾滋病毒和结核病仍然位居低收入国家十大死因之列。鉴于预算 为了进行一系列正在进行的和潜在的临床试验，我们制定了一个价值 信息 (VOI) 框架，用于正式评估哪些试验可能提供最佳价值 比较有或没有新信息（可能从试验中获得）的行动方案 量化信息获取的价值，同时考虑试验收益和成本。