Antibacterial Resistance Leadership Group (ARLG)

我们的目标是继续推进成功的、多学科的抗菌药物研究议程 抵抗运动领导小组(ARLG)。在最初的颁奖期间，ARLG的议程增加了科学性 对抗菌素耐药性的了解，并试图减轻推动其扩大的重要因素。我们 继续将一支由20多名世界顶级调查人员组成的史无前例的团队与 杜克临床研究所(DCRI)的组织卓越，该研究所是世界上最大的学术机构之一 研究机构。由于集成如此大规模的多个组件的复杂性 临床研究网络，我们的更新继续以通过高管进行集中领导为特色 委员会和双重PI方法。一名PI(福勒)主要专注于运营，另一名(钱伯斯) 主要关注科学议程。组织结构还包括科学小组委员会 致力于三个优先领域：革兰氏阴性细菌感染，革兰氏阳性细菌感染，以及 诊断。这些小组委员会由国际公认的合作调查人员支持，以 推进四个核心价值领域：1)科学专业知识；2)创新；3)指导和多样性；以及4) 网络发展。以补充诊断学和医学会的持续研究活动 在医药行业，我们的ARLG已经与这两个社区的成员建立了合作关系。 我们的长期研究目标是通过以下方式改善多重耐药(MDR)细菌感染的结果 设计和实施变革性诊断和治疗临床试验。我们的研究组合将 在治疗学上追求这一目标，通过在耐多药革兰氏阴性细菌和 通过研究抗多药耐药的非传统疗法(单抗和噬菌体) 铜绿假单胞菌。我们将通过获得FDA对宿主基因的批准来实现这一诊断目标 基于表达的诊断和通过评估快速表型检测对慢性粒细胞白血病患者的临床影响 血液感染。我们的研究议程反映了一种现实的战略，即逐步向复杂 改变惯例的审判。我们的具体目标是1)维护一个科学领导中心(SLC)， 为网络提供全面的科学和管理领导；2)维护临床运营 中心(COC)，为网络的临床研究提供运营支持、管理和监督 和试验；3)维持实验室中心(LC)，通过领导 发展、实施和评价基本实验室研究；以及4)：维持统计数据 和数据管理中心(SDMC)，通过在以下方面提供领导来推进ARLG的研究议程 生物统计学、研究设计、分析、解释和结果发布。通过推进这些特定的 AIMS，我们的更新将建立在我们最初的奖项中汇集的生产力和创新之上，以推进 该小组的科学议程，以对抗人类健康的主要威胁之一。

Our goal is to continue to advance the successful, multidisciplinary research agenda of the Antibacterial Resistance Leadership Group (ARLG). In the original award period, the ARLG agenda increased scientific knowledge of antibacterial resistance and sought to mitigate important factors that drive its expansion. We continue to pair an unprecedented team of over two dozen of the world's top investigators with the organizational excellence of the Duke Clinical Research Institute (DCRI), one of the world's largest Academic Research Organizations. Because of the complexity of integrating multiple components of such a large-scale clinical research network, our renewal continues to feature centralized leadership through an Executive Committee and a dual PI approach. One PI (Fowler) focuses primarily on operations and the other (Chambers) focuses largely on scientific agenda. The organizational structure also features Scientific Subcommittees devoted to three priority areas: Gram-negative bacterial infections, Gram-positive bacterial infections, and Diagnostics. These Subcommittees are supported by internationally recognized Collaborating Investigators to advance four core value areas: 1) Scientific Expertise; 2) Innovations; 3) Mentoring and Diversity; and 4) Network Development. To complement the ongoing research activities of both the diagnostic and the pharmaceutical industries, our ARLG has established collaborative ties with members of both communities. Our long-term research goal is to improve outcomes of multiple-drug resistant (MDR) bacterial infections by designing and conducting transformational diagnostic and therapeutic clinical trials. Our research portfolio will pursue this goal in therapeutics by conducting first-in kind strategy trials in MDR Gram-negative bacteria and MRSA and by studying nontraditional therapeutics (monoclonal antibodies and bacteriophages) against MDR Pseudomonas aeruginosa. We will pursue this goal in diagnostics by obtaining FDA approval for a host gene expression-based diagnostic and by evaluating the clinical impact of rapid phenotypic testing in patients with bloodstream infection. Our research agenda reflects a realistic strategy of incremental steps towards complex practice-changing trials. Our Specific Aims are to 1) To maintain a Scientific Leadership Center (SLC) that provides overall scientific and administrative leadership for the network; 2) To maintain a Clinical Operations Center (COC) that provides operational support, management, and oversight for the network’s clinical studies and trials; 3) To maintain a Laboratory Center (LC) that advances the ARLG research agenda by leading the development, implementation, and evaluation of essential laboratory research; and 4): To maintain a Statistics and Data Management Center (SDMC) that advances the ARLG research agenda by providing leadership in biostatistics, study design, analysis, interpretation, and publication of results. By advancing these specific aims, our renewal will build upon the productivity and innovation assembled in our original award to advance the ARLG scientific agenda against one of the leading threats to human health.