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

传染病临床研究联盟领导小组 (IDCRCLG)

基本信息

批准号：
10462071
负责人：
Kathleen Neuzil
金额：
$ 201.8万
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：
2021-07-29 至 2023-05-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462071
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 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

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.

该传染病临床研究联盟领导小组（IDCRCLG或LG）是一个新的，