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CLINICAL TRANSLATIONAL CORE

CLINICAL TRANSLATIONAL CORE
临床转化核心
批准号:
10227213
负责人:
S. Ali Fatemi
金额:
$28.32万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-08-01 至 2025-05-31

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中文摘要
翻译
项目总结/摘要-临床翻译核心 临床翻译核心(CTC)的总体目标是为IDDRC支持的研究者提供 获得对有效和高效地进行转化研究至关重要的资源 神经发育障碍CTC的服务范围从细胞培养研究到临床前动物研究, 服务(动物行为,组织学,显微镜,质谱和分子方法),以广泛的 临床试验支持,包括方案设计和生物统计分析方面的咨询, 向机构审查委员会(IRB)提交方案,并提供实践建议和帮助 由经验丰富的试验者、研究协调员和管理人员制定研究方案。该芯体的 董事和教职员工共同拥有这些服务的高水平专业知识,以及FDA 监管专业知识。反恐委员会将继续支持沿着整个T4交流想法和结论 平移连续统这反映了核心和中心共同致力于加强 将基础科学发现转化为有效的、商业上可获得的改变疾病的疗法; 为公共政策提供科学投入;并最终改善儿童和成人的成果, 智力和其他发育残疾。 核心方案的目标将通过以下目标实现:(1) 基础设施和专业知识,以支持重点在基础科学进展的转化项目, 理解智力和发育障碍(IDD);(2)指导,以协助IDD调查人员 进行临床研究及临床试验;及(3)教育活动及传播机会。
英文摘要
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.
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