Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}

传染病临床研究联盟领导小组 (IDCRCLG) - Momi-Vax DMID

• 批准号: 10428189
• 负责人: Kathleen Neuzil
• 金额: $ 225.4万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-06 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10428189
• 关键词: Address; Adopted; Ancillary Study; Area; Biological Assay; Biological Response Modifier Therapy; Clinical; Clinical Research; Clinical Trials; Collaborations; Common Data Element; Communicable Diseases; Communication; Communities; Complex; Containment; Data; Data Science; Devices; Diagnosis; Diagnostic; 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; Universities; 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, 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 will include interventional trials and clinical research studies for vaccines, biologics, therapeutics, diagnostics and devices targeting these infectious diseases. The LG's experts and their programs at the eight universities and beyond have a historic record of accomplishment in vaccine and therapeutic clinical research, and immunologic and pathogenesis studies for these NIAID-priority infectious diseases. 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 will leverage 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 proposes to establish and operate 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, 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 infectious diseases 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 will help the IDCRC to respond rapidly (surge capacity) during a 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： 这个传染病临床研究联盟领导小组（IDCRCLG或LG）是一个 主要传染病、人类免疫学和临床研究国家合作伙伴关系 来自八个杰出学术机构的专家提供经验、指导、全球联系和 创新的方法来解决NIH/NIAID临床研究的优先事项。的重点（和强度） LG将促进、规划和帮助实施呼吸道和肠道感染的临床研究， 疟疾/热带疾病和性传播感染，并应对新出现的 疾病（EID）。优先研究将包括疫苗的干预性试验和临床研究， 针对这些传染病的生物制剂、治疗剂、诊断剂和设备。LG的专家和 他们在八所大学和其他大学的项目在疫苗方面取得了历史性的成就， 和治疗性临床研究，以及这些NIAID优先的免疫学和发病机制研究 传染病LG为开展I-IV期临床试验带来了广泛的专业知识，包括首次- 人体研究、尖端人体免疫学、药代动力学;与不同人群的接触 在国内/国际上，sIRB、创新的公私合作伙伴关系和研究性新药 应用程序（IND）。该小组还与NIH/NIAID支持的网络有很强的联系，并将利用这些网络; 在与行业合作伙伴和基金会合作方面拥有丰富的经验， 行政财团。这支由各种传染病专家组成的干部队伍建议建立和运作 与NIAID和重组的疫苗和治疗评估单位（VTEU），一个综合的，高度- 功能性、高效的IDCRC在优先事项方面制定创新的科学和业务战略， 疫苗和性病临床研究。支持科学和业务的组织结构， LG由领导运营中心（包括专家工作组）、临床运营中心和 单位、实验室运营单位以及统计和数据科学单位。LG的主要功能是 提出、审查创新概念并确定其优先次序;加强业务的一体化和效率; 成立合作小组;确保高质量和及时地执行议定书;传播成果; 促进所有人群在整个人类生命周期内参与IDCRC研究;并吸引、参与 留住下一代传染病临床研究的科学家。此外，LG的 应对EID威胁的经验，与全球合作伙伴/研究中心的链接，最高级别的临床和实验室访问 控制设施和大量人口将有助于IDCRC快速响应（激增能力）， 突发公共卫生事件LG在公共卫生、监管机构、 产品开发管道进一步加强了这一能力。LG和所代表的机构是 通过专门的PI/领导努力、空间、基础设施和直接资金致力于发展IDCRC。