CLINICAL TRANSLATIONAL CORE

项目摘要/摘要-临床翻译核心 临床翻译核心(CTC)的总体目标是提供IDDRC支持的研究人员 获取对有效和高效地开展翻译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 服务(动物行为、组织学、显微镜、质谱学和分子方法)，广泛 临床试验支持，包括关于方案设计和生物统计分析的咨询，在 向机构审查委员会(IRB)提交议定书，并实际提供咨询意见和帮助执行 由经验丰富的试验人员、研究协调员和行政人员制定的调查方案。核心的 董事和教职员工共同拥有这些服务部门以及FDA的高水平专业知识 监管专业知识。反恐委员会将继续支持思想和调查结果在整个T4中的传播 翻译连续体。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结果 智力和其他发育障碍。 核心的目标将通过以下目标实现：(1) 支持项目所需的基础设施和专业知识，这些项目侧重于将基础科学进展转化为 对智力和发育障碍(IDD)的了解；(2)指导以协助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。

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.