Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG)

传染病临床研究联盟领导小组 (IDCRCLG)

• 批准号: 10265698
• 负责人: Kathleen Neuzil
• 金额: $ 93.4万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-24 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10265698
• 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

This Infectious Diseases Clinical Research Consortium Leadership Group (IDCRCLG or LG) is a new, 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 IDCRCLG 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 IDCRCLG 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 the 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 IDCRCLG and the institutions they represent are committed through dedicated PI/leadership effort, space, infrastructure and direct funds to develop the IDCRC.

这种传染病临床研究联盟领导力小组（IDCRCLG或LG）是一个新的，是一个新的， 领先的传染病，人类免疫学和临床研究的合作民族合作伙伴关系 来自八个杰出学术机构的专家提供经验，指导，全球连通性和 解决NIH/NIAID临床研究重点的创新方法。重点（和力量） IDCRCLG将促进，计划和帮助实施呼吸道和促进感染的临床研究， 疟疾/热带疾病和性传播感染（性传播感染），并应对新兴 传染病（EID）。优先研究将包括介入的试验和临床研究 针对这些传染病的疫苗，生物制剂，治疗，诊断和设备。 LG的 专家及其在八所大学及以后的计划都具有历史性的成就记录 疫苗和热临床研究，以及这些NIAID优先性的免疫学和发病机理研究 传染病。 LG通过进行I-IV期临床试验（包括首先 人类内部研究，尖端的人类免疫学，药代动力学；与潜水员人口互动 在国内/国际上，SIRBS，创新的公私合作伙伴关系和调查新药 应用（IND）。该小组还与NIH/NIAID支持的网络具有牢固的连接性，并将利用NIH/NIAID支持的网络； 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 行政财团。这位潜水员传染病的干部提出了建立和运营的建议 NIAID和重构疫苗和治疗评估单位（VTEUS），一个综合，高度 - 功能性，有效的IDCRC，以在优先事项中制定创新的科学和运营策略 疫苗和STI临床研究。支持科学和运营的组织结构 IDCRCLG由领导力运营中心组成，包括专家工作组，一个临床 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 参与并保留了下一代科学家在传染病中的临床研究。此外，LG 具有开斋节威胁的经验，与全球合作伙伴/站点的链接，访问最高级别的临床和实验室的经验 遏制设施和大量人口将有助于IDCRC在 公共卫生紧急情况。 LG在公共卫生，监管机构，产品方面的经验数十年 开发管道进一步增强了这一能力。 IDCRCLG及其代表的机构是 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。