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： 该传染病临床研究联盟领导小组（IDCRCLG 或 LG）是 主要传染病（ID）、人类免疫学和临床的国家合作伙伴关系 来自八个杰出学术机构的研究专家提供经验、指导、全球 解决 NIH/NIAID 临床研究优先事项的连通性和创新方法。 LG 的（和优势）是促进、规划和帮助实施呼吸系统和疾病的临床研究 肠道感染、疟疾/热带疾病和性传播感染 (STI)，并应对 新发传染病（EID）的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、治疗方法、诊断方法和设备的研究。 LG 的专家及其项目在疫苗和治疗临床方面取得了历史性的成就 LG 为这些 NIAID 优先 ID 进行了广泛的研究、免疫学和发病机制研究。 具有进行 I-IV 期临床试验的专业知识，包括首次人体研究、尖端人体研究 免疫学、药代动力学；与国内/国际不同人群的接触、sIRB、 该小组还开展创新的公私合作伙伴关系和研究性新药申请（IND）。 与 NIH/NIAID 支持的网络具有强大的连接性并利用其丰富的经验； 与行业合作伙伴和基金会合作，以及复杂的行政联盟的领导。 这支由不同传染病专家组成的骨干队伍与 NIAID 和 重组疫苗和治疗评估单元 (VTEU)，一个集成的、功能强大的、高效的 IDCRC 将针对疫苗和性传播感染等优先事项制定创新的科学和运营战略 支持 LG 科学和运营的组织结构由以下组成： 领导运营中心，包括专家工作组、关键职能委员会、临床 运营部门、实验室运营部门以及统计和数据科学部门的主要职能。 LG 将提出、审查并优先考虑创新概念，以增强一体化和效率； 运营；组建协作团队；确保协议的质量和及时传播； 结果；促进所有人群在整个人类生命周期中融入 IDCRC 研究； 吸引并留住下一代科学家进行 ID 临床研究 此外，LG 的经验。 应对 EID 威胁、与全球合作伙伴/站点的链接、获得最高级别的临床和实验室遏制 设施和大量人口使其能够对新冠病毒做出快速反应（激增能力） - 1 9 公共卫生紧急事件 LG 在公共卫生、监管机构、 产品开发渠道进一步增强了 LG 和代表机构的这种能力。 致力于通过专门的 PI/领导力努力、空间、基础设施和直接资金来发展 IDCRC。