NINDS NEXT: Children's Hospital Boston Clinical Research Site

描述（由申请人提供）：进行临床试验的障碍和挑战阻碍了科学知识的提高和神经系统疾病诊断和治疗的进步。NEXT模型的创新方面旨在克服这些障碍。波士顿儿童医院神经内科拥有资源、人员、患者数量、机构支持、研究专业知识和奉献精神，使其成为NEXT临床研究中心（CRS）专注于儿童神经病学的合理选择。该提案的具体目标是：(1)将波士顿儿童医院NEXT CRS发展为共享的基础设施平台，并为CRS领导层和员工分配角色；(2)确定和招募符合NEXT和NINDS试验的患者，并确定可用的疾病特异性患者群体的范围；(3)提交网络审查的试验申请，被任命为NEXT未来研究的牵头CRS，并展示开展临床研究的经验和专业知识；(4)与NEXT数据协调中心合作，展示在出版和传播研究成果方面的专业知识；(5)遵守规范的网络政策，执行和优化机构、部门、部门和个人合作协议的参数；(6)培训新的临床研究人员在临床研究中独立职业所需的技能，并确定CRS将最大限度地利用当地临床研究教育和支持服务的方法。

DESCRIPTION (provided by applicant): Barriers and challenges to the conduct of clinical trials are obstacles to the improvement of scientific knowledge and the advancement of diagnosis and treatments for neurologic disorders. The innovative aspects of the NEXT model are aimed at overcoming these barriers. The Department of Neurology at Children's Hospital Boston has the resources, personnel, patient population, institutional support, research expertise, and dedication that make it the logical choice for a NEXT Clinical Research Site (CRS) focused on pediatric neurology. The Specific Aims of this proposal are: (1) to develop the Children's Hospital Boston NEXT CRS as a shared infrastructure platform and assign roles for CRS leadership and staff; (2) to identify and recruit eligible patients for NEXT and NINDS trials and establish the extent of available disease-specific patient populations; (3) to submit trial applications for Network review, be named lead CRS on a future NEXT study, and demonstrate experience and expertise in the conduct of clinical research; (4) to collaborate with the NEXT Data Coordinating Center and demonstrate expertise in publication and dissemination of research results; (5) to abide by standardized Network policies and implement and optimize parameters of institutional, divisional, departmental, and individual collaborative agreements; and (6) to train new clinical investigators in skills required for an independent career in clinica research and identify means by which the CRS will maximize co-investigator use of local clinical research educational and support services.