Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - COVAIL DMID #22-0004

传染病临床研究联盟领导小组 (IDCRCLG) - COVAIL DMID

• 批准号: 10615472
• 负责人: Kathleen Neuzil
• 金额: $ 24.01万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-02 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10615472
• 关键词: Address; Adopted; Ancillary Study; Area; Biological Assay; Biological Products; Clinical; Clinical Research; Clinical Trials; Collaborations; Common Data Element; Communicable Diseases; Communication; Communities; Complex; Containment; Data; Data Science; Diagnosis; Diagnostic Equipment; Diarrhea; Dissemination and Implementation; Drug Kinetics; Ebola; Elements; Emerging Communicable Diseases; Ensure; Environment; Epidemic; Ethics; Evaluation; Foundations; Funding; Future; Genomics; Human; Immunologics; Immunology; Infection; Influentials; Infrastructure; Institution; International; Intervention Trial; Investigational New Drug Application; Laboratories; Laboratory Research; Leadership; Link; Longevity; Malaria; Mentors; Methods; Monitor; National Institute of Allergy and Infectious Disease; Outcome; Participant; Pathogenesis; Patients; Performance; Phase; Policies; Population; Population Heterogeneity; Prevention; Private Sector; Procedures; Proteomics; Protocols documentation; Public Health; Publications; Research; Research Activity; Research Design; Research Priority; Resources; Respiratory Tract Infections; Risk Assessment; Science; Scientist; Services; Sexually Transmitted Diseases; Site; Specimen; Systems Biology; Techniques; Therapeutic; Time; Training; Translating; Tropical Disease; Underserved Population; United States; United States National Institutes of Health; Vaccines; Vulnerable Populations; ZIKA; career development; clinical application; data management; drug discovery; enteric infection; experience; first-in-human; flexibility; global health; improved; industry partner; infectious disease treatment; influenza pneumonia; innovation; laboratory experiment; lipidomics; metabolomics; microbial; microbiome; multi-site trial; next generation; novel; novel strategies; operation; organizational structure; performance site; product development; programs; protocol development; public health emergency; public-private partnership; reconstitution; research study; risk mitigation; support network; transcriptomics; trial design; vaccine evaluation; vaccine trial; working group

IDCRC LG Project Summary/Abstract: This Infectious Diseases Clinical Research Consortium Leadership Group (IDCRCLG or LG) is a collaborative national partnership of leading infectious diseases (ID), human immunology and clinical research experts from eight outstanding academic institutions providing experience, guidance, global connectivity and innovative approaches to address NIH/NIAID clinical research priorities. The emphasis (and strength) of the LG is to facilitate, plan and help implement clinical research for respiratory and enteric infections, malaria/tropical diseases, and sexually transmitted infections (STIs), and to respond to emerging infectious diseases (EID). Priority research includes interventional trials and clinical research studies for vaccines, biologics, therapeutics, diagnostics and devices targeting infectious diseases. The LG’s experts and their programs have a historic record of accomplishment in vaccine and therapeutic clinical research, and immunologic and pathogenesis studies for these NIAID-priority ID’s. The LG brings extensive expertise with the conduct of Phase I-IV clinical trials including first- in-human studies, cutting-edge human immunology, pharmacokinetics; engagement with diverse populations both nationally/internationally, sIRBs, innovative public-private partnerships, and Investigational New Drug applications (INDs). The group also has strong connectivity to and leverages NIH/NIAID-supported networks; extensive experience in collaborating with industry partners and foundations, and leadership of complex administrative consortia. This cadre of diverse infectious diseases experts has established and operates with NIAID and the reconstituted Vaccine and Treatment Evaluation Units (VTEUs), an integrated, highly- functional, efficient IDCRC to develop innovative scientific and operational strategies in priorities such as vaccines and STI clinical research. The organizational structure supporting the science and operations of the LG is composed of a Leadership Operations Center including Expert Working Groups, Key Function Committees, a Clinical Operations Unit, a Laboratory Operations Unit, and a Statistical and Data Science Unit. Key functions of the LG are to propose, review and prioritize innovative concepts; to enhance integration and efficiency in operations; to form collaborative teams; to ensure quality and timely protocol implementation; to disseminate results; to promote integration of all populations in IDCRC research across the human lifespan; and to attract, engage and retain the next generation of scientists in ID clinical research. In addition, the LG’s experience with EID threats, links to global partners/sites, access to the highest-level clinical and laboratory containment facilities and to large populations has allowed it to respond rapidly (surge capacity) t o t h e C O V I D - 1 9 public health emergency. The LG’s decades of experience with public health, regulatory agencies, product development pipelines further enhance this capacity. The LG and the institutions represented are committed through dedicated PI/leadership effort, space, infrastructure and direct funds to develop the IDCRC.

IDCRC LG项目摘要/摘要： 这种传染病临床研究联盟领导力小组（IDCRCLG或LG）是 领先的传染病（ID），人类免疫学和临床合作伙伴关系 来自八个杰出学术机构的研究专家提供经验，指导，全球 连通性和创新方法可解决NIH/NIAID临床研究重点。重点 LG的（和力量）是促进，计划和帮助实施呼吸道和 肠道感染，疟疾/热带疾病和性传播感染（ETI），并应对 新兴的传染病（EID）。优先研究包括介入试验和临床研究 针对传染病的疫苗，生物制剂，治疗，诊断和设备的研究。这 LG的专家及其计划在疫苗和治疗临床方面具有历史性的成就记录 这些NIAID-优先ID的研究以及免疫学和发病机理研究。 LG带来了广泛的 I-IV期临床试验的进行专业知识，包括第一研究，最先进的人类 免疫学，药代动力学；在国内/国际上与潜水员的互动，Sirbs，Sirbs， 创新的公私合作伙伴关系和调查新药应用（IND）。小组也是如此 与NIH/NIAID支持的网络具有牢固的连通性和利用；丰富的经验 与行业合作伙伴和基金会合作，以及复杂行政财团的领导。 这位潜水传染病专家的干部已经建立并与Niaid和 重构的疫苗和治疗评估单位（VTEUS），一种综合，功能高效，有效的 IDCRC以疫苗和STI等优先事项制定创新的科学和运营策略 临床研究。支持LG的科学和运营的组织结构是组成的 领导力运营中心（包括专家工作组，关键功能委员会，临床） 运营部门，实验室操作部门以及统计和数据科学部门。关键功能 LG将提出，审查和优先考虑创新概念；提高整合和效率 运营;组成合作团队；确保质量和及时的协议实施；传播 结果;促进整个人类寿命的IDCRC研究中所有人群的整合；并吸引 参与并保留下一代科学家在ID临床研究中。此外，LG的经验 有开斋节威胁，链接到全球合作伙伴/站点，访问最高级别的临床和实验室遏制 设施和大量人口使其能够迅速响应（激增的能力） 1 9公共卫生紧急情况。 LG在公共卫生，监管机构中的数十年经验， 产品开发管道进一步增强了这一能力。 LG和所代表的机构是 通过专门的PI/领导力，空间，基础架构和直接资金来开发IDCRC的实施。