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

基本信息

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
项目类别：
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

项目摘要

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：该传染病临床研究联盟领导小组（IDCRCLG 或 LG）是主要传染病、人类免疫学和临床研究的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、全球联系和解决 NIH/NIAID 临床研究优先事项的创新方法。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/热带病和性传播感染（STI），并应对新出现的传染病疾病（EID）。优先研究将包括疫苗的介入试验和临床研究，针对这些传染病的生物制剂、治疗方法、诊断方法和设备。 LG 的专家和他们在八所大学及其他大学的项目在疫苗方面取得了历史性的成就针对这些 NIAID 优先事项的治疗性临床研究、免疫学和发病机制研究传染病。 LG 带来了开展 I-IV 期临床试验的丰富专业知识，包括首次- 人体研究、尖端人类免疫学、药代动力学；与不同人群的接触国内/国际、sIRB、创新的公私伙伴关系和研究性新药申请（IND）。该小组还与 NIH/NIAID 支持的网络建立了强大的连接，并将利用该网络；与行业合作伙伴和基金会合作的丰富经验，以及复杂的领导力行政财团。这支由不同传染病专家组成的骨干队伍提议建立和运作与 NIAID 和重建的疫苗和治疗评估单位 (VTEU) 一起，一个综合的、高度功能齐全、高效的 IDCRC 在优先事项中制定创新的科学和运营战略，例如疫苗和性传播感染临床研究。支持科学和运营的组织结构 LG 由一个领导运营中心（包括专家工作组）、一个临床运营中心组成单位、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顺序；提高运营的整合度和效率；到组建协作团队；确保协议的质量和及时实施；传播结果；到促进所有人群在整个人类生命周期中融入 IDCRC 研究；并吸引、参与并保留下一代从事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/站点的链接、访问最高水平的临床和实验室的机会收容设施和大量人口将有助于 IDCRC 在突发公共卫生事件。 LG 在公共卫生、监管机构、产品开发渠道进一步增强了这种能力。地方政府和代表机构是致力于通过专门的 PI/领导力努力、空间、基础设施和直接资金来发展 IDCRC。