CLINICAL TRANSLATIONAL CORE

临床转化核心

基本信息

批准号：
10677579
负责人：
S. Ali Fatemi
金额：
$ 28.33万
依托单位：
HUGO W. MOSER RES INST KENNEDY KRIEGER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10677579
关键词：
Adult Advocacy Animal Behavior Animal Model Animals Applications Grants Autopsy Basic Science Biochemical Biochemistry Biological Assay Biometry Breeding Cell Culture Techniques Certification Child Childhood Clinic Clinical Clinical Laboratory Improvement Amendments Clinical Research Clinical Trials Collaborations Communities Conduct Clinical Trials Consultations Development Developmental Disabilities Disease Educational Activities Enzymes Faculty Fibroblasts Follow-Up Studies Funding Genotype Goals Grant Review Histology Human IACUC In Vitro Industry Infrastructure Institutional Review Boards Intellectual and Developmental Disabilities Research Centers Intellectual functioning disability Knowledge Laboratories Lipids Marketing Mass Spectrum Analysis Medical Students Mentors Metabolic Methods Microscopy Microsurgery Molecular Movement National Institute of Child Health and Human Development Neurodevelopmental Disorder Neurons Operative Surgical Procedures Pathogenesis Phenotype Policy Maker Prevention Protocols documentation Public Policy Research Research Methodology Research Personnel Resources Rodent Services Technology Transfer Training Transgenic Animals Translational Research Translations Universities career clinical translation design developmental disease experience falls improved improved outcome induced pluripotent stem cell innovation live cell imaging member neurobehavioral test neurophysiology pre-clinical programs symposium tandem mass spectrometry translational model translational neuroscience

项目摘要

PROJECT SUMMARY/ABSTRACT – CLINICAL TRANSLATIONAL CORE The overall objective of the Clinical Translational Core (CTC) is to provide IDDRC-supported investigators access to resources that are critically important for the effective and efficient conduct of translational research of neurodevelopmental disorders. The CTC’s services range from cell culture studies, to preclinical animal services (animal behavior, histology, microscopy, mass spectrometry and molecular methods), to extensive clinical trial support, including consultation on protocol design and biostatistical analyses, pre-review prior to submission of protocols to the institutional review board (IRB), and hands-on advice and help with carrying out investigational protocols by experienced trialists, research coordinators and administrative staff. The Core’s directors and faculty members collectively have a high level of expertise across these services, as well as FDA regulatory expertise. The CTC will continue to support the movement of ideas and findings along the entire T4 translational continuum. This reflects the Core’s and the Center’s shared commitment to enhancing the conversion of basic science discoveries into effective, commercially available disease-altering therapies; to provide scientific input towards public policy; and, ultimately, to improve outcomes for children and adults with intellectual and other developmental disabilities. The objective of the Core will be achieved through the following Aims, which are to provide: (1) infrastructure and expertise needed to support projects focused on translation of basic science advances in the understanding of intellectual and developmental disabilities (IDD); (2) mentoring to assist IDD investigators in conducting clinical research and clinical trials; and (3) educational activities and dissemination opportunities.

项目摘要/摘要——临床转化核心临床转化核心 (CTC) 的总体目标是为 IDDRC 支持的研究人员提供获取对于有效且高效地进行转化研究至关重要的资源 CTC 的服务范围从细胞培养研究到临床前动物。服务（动物行为、组织学、显微镜、质谱和分子方法），以广泛临床试验支持，包括方案设计和生物统计分析咨询、试验前预审向机构审查委员会 (IRB) 提交方案，并提供实践建议和帮助由经验丰富的试验人员、研究协调员和管理人员制定的研究方案。董事和教职人员在这些服务以及 FDA 方面都拥有高水平的专业知识 CTC 将继续支持整个 T4 的想法和研究成果的传播。这反映了核心和中心对加强将基础科学发现转化为有效的、商业化的疾病改变疗法；为公共政策提供科学投入，并最终改善儿童和成人的治疗结果；智力和其他发育障碍。核心目标将通过以下目标实现，即：(1) 支持重点关注基础科学进展转化的项目所需的基础设施和专业知识了解智力和发育障碍 (IDD)；(2) 指导协助 IDD 调查人员进行临床研究和临床试验；(3) 教育活动和传播机会。