NINDS NEXT: Children's Hospital Boston Clinical Research Site

NINDS NEXT：波士顿儿童医院临床研究基地

• 批准号: 8729028
• 负责人: BASIL T DARRAS
• 金额: $ 34.36万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8729028
• 关键词: Agreement; Biological Markers; Boston; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; Data Collection; Data Coordinating Center; Data Quality; Databases; Dedications; Development; Diagnosis; Disease; Enrollment; Funding; Future; Goals; Human Resources; Ice; Individual; Informed Consent; Institutional Review Boards; Knowledge; Lead; Leadership; Medical; Mentors; Modeling; Monitor; Names; National Institute of Neurological Disorders and Stroke; Neurology; Online Systems; Patients; Pediatric Hospitals; Pediatric Neurology; Peer Review; Phase; Physicians; Policies; Positioning Attribute; Procedures; Process; Protocols documentation; Publications; Recruitment Activity; Request for Applications; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Resources; Role; Services; Spinal Muscular Atrophy; Training; Translations; career; clinical research site; dissemination research; effective therapy; experience; improved; innovation; member; nervous system disorder; patient population; research study; response; skills; therapeutic development

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.

描述（由申请人提供）：开展临床试验的障碍和挑战是提高科学知识和推进神经系统疾病诊断和治疗的障碍。NEXT模式的创新方面旨在克服这些障碍。波士顿儿童医院神经科拥有资源，人员，患者人群，机构支持，研究专业知识和奉献精神，使其成为专注于儿科神经学的NEXT临床研究中心（CRS）的合理选择。本提案的具体目标是：（1）将波士顿儿童医院NEXT CRS开发为共享基础设施平台，并为CRS领导层和工作人员分配角色;（2）识别和招募NEXT和NINDS试验的合格患者，并确定可用疾病特异性患者人群的范围;（3）提交试验申请进行网络审查，在未来的NEXT研究中被任命为CRS负责人，并展示临床研究的经验和专业知识;（4）与NEXT数据协调中心合作，并在研究成果的出版和传播方面展示专业知识;（5）遵守标准化的网络政策，实施和优化机构、部门、部门和个人合作协议的参数;和（6）培训新的临床研究者在临床研究中独立工作所需的技能，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合作研究者的方法。