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

项目总结 在高负担国家，许多结核病患者从未得到有效药物的诊断或治疗。 治疗方案，导致持续传播和增加死亡率。一个主要原因是当前的结核病 诊断是不够的，关键问题包括灵敏度不高、成本高、无法在 卫生系统水平较低和/或未能识别抗药性。没有一项测试可能能解决所有问题 这些局限性，因此世界卫生组织(WHO)已经描述了最佳检测特征 以目标产品简介(TPP)的形式针对不同的用例。为高优先级提出新的解决方案 TPP，确定有前景的技术并将其开发人员链接到经验丰富的临床研究站点 促进评估和绩效反馈是必不可少的。 结核病诊断网络(R2D2 TB网络)快速开发研究的总体目标 是解决对更好的结核病诊断的关键的未得到满足的需求，以便弥合“诊断差距”和 从而改善患者和公共卫生结果。为了实现这一目标，R2D2 TB网络将征集、 在开发的不同阶段审查最相关的新型结核病诊断并确定其优先顺序 在授奖期间对不同的用例进行评估(目标1)。我们将利用我们的 与生物技术孵化器合作，引进尚未在结核病领域工作的技术创新者，以及 与一个关键的非政府组织合作，该非政府组织一直是发展当前结核病诊断管道的领导者。临床研究： 在开发的早期阶段评估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、多中心的 设计锁定诊断的准确性和可用性，以促进世卫组织政策审查(目标3)。临床部 研究将严格遵循世卫组织针对特定用例的指导方针以及针对高... 质量诊断评估。对于设计锁定的诊断，我们将补充临床研究 通过经验成本计算、卫生经济和传播模型评估增量价值 研究(目标4)进一步支持世卫组织和国家一级的政策审查。 为了实现这些目标，R2D2结核病网络将调查人员与范围广泛的 与结核病诊断研究相关的专业知识和10个高负荷地区的12个经验丰富的临床研究地点 向相关人群提供评估结核病诊断的途径的国家。监督的私隐专员 网络在协调多中心研究方面拥有深厚的专业知识，具有与 广泛的产品开发人员、世卫组织审查和认可做法的经验以及 监管机构，以及十多年的协作领导经验。通过培养和 支持由调查人员、产品开发人员和利益相关者组成的强大协作网络 在不同的地理位置，R2D2结核病网络将推动下一代结核病诊断。

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.