Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Moderna Boost {Supplement #5}

传染病临床研究联盟领导小组 (IDCRCLG) - Moderna Boost {补充

• 批准号: 10403051
• 负责人: Kathleen Neuzil
• 金额: $ 47.3万
• 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: 2021-07-27 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10403051
• 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.

国际儿童权利中心LG项目摘要/摘要： 传染病临床研究联盟领导小组(IDCRCLG或LG)是一个 在领先的传染病、人类免疫学和临床研究方面建立国家合作伙伴关系 来自八个杰出学术机构的专家提供经验、指导、全球连接和 解决NIH/NIAID临床研究优先事项的创新方法。的重点(和力量) LG将促进、计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，以及应对新出现的传染病 疾病(开斋节)。重点研究将包括疫苗的干预试验和临床研究， 针对这些传染病的生物制剂、治疗、诊断和设备。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，以及免疫学和发病机制研究 传染病。LG在进行I-IV期临床试验方面提供了广泛的专业知识，包括第一- 人体内研究、尖端人类免疫学、药代动力学；与不同人群接触 国家/国际、小岛屿发展中国家、创新的公私伙伴关系和研究新药 应用程序(IND)。该小组还与NIH/NIAID支持的网络建立了强有力的连接，并将利用这些网络； 具有与行业合作伙伴和基金会协作的丰富经验，以及对Complex的领导能力 行政联合体。这支由不同传染病专家组成的干部团队建议建立和运作 有了NIAID和重组的疫苗和治疗评估单位(VTEU)，一个集成的、高度... 在优先事项方面制定创新的科学和业务战略，如 疫苗和性传播感染临床研究。支持科学和业务的组织结构 LG由包括专家工作组在内的领导运营中心、临床运营中心组成 一个实验室业务股和一个统计和数据科学股。LG的主要职能是 提出、审查和确定创新概念的优先次序；提高业务一体化和效率； 组建协作团队；确保高质量和及时执行议定书；传播成果； 在人的一生中促进所有人口融入国际儿童权利中心的研究；并吸引、参与 并留住下一代科学家从事传染病临床研究。此外，LG的 应对宰牲节威胁的经验、全球合作伙伴/站点的链接、访问最高级别的临床和实验室 遏制设施和大量人口将有助于儿童权利委员会在以下期间迅速作出反应(激增能力) 这是一场突发公共卫生事件。LG在公共卫生、监管机构、 产品开发管道进一步增强了这一能力。LG和代表的机构是 通过专门的非政府组织/领导努力、空间、基础设施和直接资金承诺发展国际儿童权利中心。