Rapid Research for Diagnostics Development in TB Network (R2D2 TB Network)

结核病网络诊断开发快速研究（R2D2 结核病网络）

• 批准号: 10244868
• 负责人: Adithya Cattamanchi
• 金额: $ 399.64万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-21 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10244868
• 关键词: Address; Algorithms; Award; Biotechnology; Caring; Characteristics; Clinical Research; Complement; Country; Data; Development; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Drug resistance; Drug resistance in tuberculosis; Ensure; Epidemiology; Evaluation; Extreme drug resistant tuberculosis; Failure; Feedback; Fostering; Foundations; Geographic Locations; Geography; Goals; Guidelines; Health Status; Health system; Incubators; Laboratories; Leadership; Link; Medicine; Modeling; Multicenter Studies; Organizational Policy; Outcome; Patients; Performance; Pharmaceutical Preparations; Phase; Policies; Population; Process; Public Health; Recording of previous events; Regimen; Research; Research Personnel; Resistance; Site; Special Population; Specific qualifier value; Structure; Study models; Technology; Testing; Tuberculosis; Update; Validation; World Health Organization; authority; clinical research site; cost; cost effective; data modeling; design; diagnostic accuracy; disease diagnosis; experience; field study; flexibility; health economics; improved; innovation; innovative technologies; mortality; next generation; novel; novel diagnostics; prototype; transmission process; tuberculosis diagnostics; usability; Address; Algorithms; Award; Biotechnology; Caring; Characteristics; Clinical Research; Complement; Country; Data; Development; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Drug resistance; Drug resistance in tuberculosis; Ensure; Epidemiology; Evaluation; Extreme drug resistant tuberculosis; Failure; Feedback; Fostering; Foundations; Geographic Locations; Geography; Goals; Guidelines; Health Status; Health system; Incubators; Laboratories; Leadership; Link; Medicine; Modeling; Multicenter Studies; Organizational Policy; Outcome; Patients; Performance; Pharmaceutical Preparations; Phase; Policies; Population; Process; Public Health; Recording of previous events; Regimen; Research; Research Personnel; Resistance; Site; Special Population; Specific qualifier value; Structure; Study models; Technology; Testing; Tuberculosis; Update; Validation; World Health Organization; authority; clinical research site; cost; cost effective; data modeling; design; diagnostic accuracy; disease diagnosis; experience; field study; flexibility; health economics; improved; innovation; innovative technologies; mortality; next generation; novel; novel diagnostics; prototype; transmission process; tuberculosis diagnostics; usability

PROJECT SUMMARY In high burden countries, many patients with tuberculosis (TB) are never diagnosed or treated with effective drug regimens, leading to ongoing transmission and increased mortality. A primary reason is that current TB diagnostics are inadequate with key issues including inadequate sensitivity, high costs, inability to be used at lower levels of the health system and/or failure to identify drug resistance. No single test is likely to address all these limitations and therefore the World Health Organization (WHO) has described optimal test characteristics for different use-cases in the form of target product profiles (TPPs). To advance novel solutions for high priority TPPs, identifying promising technologies and linking their developers to experienced clinical study sites to facilitate evaluation and performance feedback is essential. The overall goal of the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) is to address the critical unmet need for better TB diagnostics in order to close the “diagnostic gap” and thereby improve patient and public health outcomes. To achieve this goal, the R2D2 TB Network will solicit, review and prioritize the most relevant novel TB diagnostics across different phases of development and across different use cases for evaluation during the award period (Objective 1). We will leverage our partnership with a biotech incubator to bring in technology innovators not already working in the TB field and with a key NGO that has been a leader in developing the current TB diagnostics pipeline. Clinical studies to assess accuracy and usability of tests in earlier phases of development will allow for iterative test optimization (Objective 2). These studies will be nested, where possible, within large-scale, multi-center assessments of the accuracy and usability of design-locked diagnostics to facilitate WHO policy review (Objective 3). The clinical studies will rigorously follow WHO guidance for specific use-cases as well as general guidelines for high- quality diagnostic evaluations. For design-locked diagnostics, we will complement the clinical studies with assessments of incremental value through empirical costing, health economic and transmission modeling studies (Objective 4) to further support WHO- and country-level policy reviews. To accomplish these objectives, the R2D2 TB Network brings together investigators with a broad range of relevant expertise related to TB diagnostic research and 12 experienced clinical study sites in 10 high-burden countries that provide access to relevant populations for evaluating TB diagnostics. The PIs overseeing the network have deep expertise in coordination of multi-center studies, a demonstrated history of working with a broad range of product developers, experience in the review and endorsement practices of the WHO and regulatory authorities, and more than a decade of collaborative leadership experience. By fostering and supporting a strong, collaborative network of investigators, product developers and stakeholders across diverse geographic sites, the R2D2 TB Network will advance the next-generation of TB diagnostics.

项目摘要 在高伯恩国家，许多结核病患者（TB）从未被诊断或治疗有效药物 方案，导致持续传播和死亡率增加。一个主要原因是当前结核 诊断不足以充分利用关键问题，包括敏感性不足，高成本，无法使用 卫生系统的较低水平和/或无法识别耐药性。没有一个测试可以解决所有问题 这些限制，因此世界卫生组织（WHO）描述了最佳测试特征 针对目标产品概况（TPP）形式的不同用例。优先提高新颖的解决方案 TPP，确定有希望的技术，并将其开发人员与经验丰富的临床研究地点联系起来 促进评估和绩效反馈至关重要。 结核网络诊断开发快速研究的总体目标（R2D2 TB网络） 是为了解决对更好的结核病诊断的关键需求，以弥补“诊断差距”和 从而改善患者和公共卫生的结果。为了实现这一目标，R2D2 TB网络将征求， 审查并优先考虑在开发的不同阶段和 在奖励期内，在不同的用例中进行评估（目标1）。我们将利用我们的 与生物技术孵化器的合作伙伴关系，以引入尚未在结核病领域工作的技术创新者 有一个主要的非政府组织，它一直是开发当前结核病诊断管道的领导者。临床研究 评估早期开发阶段测试的准确性和可用性将允许迭代测试优化 （目标2）。这些研究将在可能的情况下嵌套在大规模的多中心评估中 设计锁定诊断的准确性和可用性可促进谁政策审查（目标3）。临床 研究将严格遵循谁针对特定用例的指南以及高级指南 质量诊断评估。对于设计锁定的诊断，我们将完成临床研究 通过经验成本，健康经济和传播建模评估增量价值 研究（目标4），以进一步支持谁和国家级政策评论。 为了实现这些目标，R2D2 TB网络将调查员聚集在一起 与结核病诊断研究有关的相关专业知识和12个高负担中的12个经验丰富的临床研究站点 提供有关评估结核病诊断的相关人群的国家。 PI负责 网络在多中心研究的协调方面具有深厚的专业知识，这证明了与 广泛的产品开发人员，WHO和 监管机构，以及十多年的协作领导经验。通过寄养和 支持强大的，合作的研究人员，产品开发人员和利益相关者的网络 R2D2 TB网络不同地理位置将推进结核病诊断的下一代。