Antibacterial Resistance Leadership Group (ARLG)

描述（由申请人提供）：我们的目标是创建和实施一个抗菌耐药性领导小组（ARLG），该小组将开发、设计、实施和管理临床研究议程，以增加对驱动耐药性的重要因素的了解并减轻这些因素。我们将与杜克临床研究所（Duke Clinical Research Institute， DCRI）——世界上最大的学术研究机构之一——的卓越组织合作，组建一支由20多名世界顶级研究人员组成的前所未有的团队。由于整合如此大规模临床研究网络的多个组成部分的复杂性，我们的提交具有通过执行委员会和双PI方法集中领导的特点。一个PI（福勒）主要关注业务，另一个PI（钱伯斯）主要关注科学议程。以ACTG为蓝本的组织结构还设有专门负责四个优先领域的科学小组委员会：革兰氏阴性细菌感染、管理和感染预防、革兰氏阳性细菌感染以及诊断和设备。这些小组委员会由三个特别重点小组（儿科、药代动力学和特殊人群）和一个指导核心提供支持。每个小组委员会，SEP和核心包含国际公认的调查员，确保专业知识。为了补充目前NIH和制药生物技术行业的研究活动，我们的ARLG与两个社区的成员建立了合作关系。

DESCRIPTION (provided by applicant): Our goal is to create and implement an Antibacterial Resistance Leadership Group (ARLG) that will develop, design, implement, and manage a clinical research agenda that will increase knowledge of and mitigate the important factors that drive resistance. We will 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 submission features 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, modeled after that of the ACTG, also features Scientific Subcommittees devoted to four priority areas: Gram-negative bacterial infections, Stewardship and infection prevention, Gram-positive bacterial infections, and Diagnostics and devices. These Subcommittees are supported by three Special Emphasis Panels (SEPs) (Pediatrics, Pharmacokinetics, and Special Populations) and a Mentoring Core. Each Subcommittee, SEP, and Core contains internationally recognized investigators, ensuring expertise. To complement the current research activities of both NIH and the pharmaceutical biotechnology industry, our ARLG has established collaborative ties with members of both communities. Our long-term goals are 1) to complete a superiority trial of new anti-infectives (either new agent or new dosing regimen of existing agent) for MDR-Gram negative bacterial infections; 2) to define shorter course, narrow-spectrum therapeutic regimens for common infections as a principal means to support stewardship; 3) to test a rapid diagnostic that identifies antimicrobial resistance based on genotypic markers in bacteria; and 4) to identify a more effective alternative to vancomycin for MRSA infections. The research agenda reflects our overall strategy of making realistic, incremental steps in early phase studies upon which to build toward more complex transformational trials that will change clinical practice and reduce the impact of antibacterial resistance.