Mount Sinai Network of Excellence in Neuroscience Clinical Trials

西奈山神经科学临床试验卓越网络

• 批准号: 10188659
• 负责人: Nathalie Jette
• 金额: $ 33.9万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10188659
• 关键词: Adult; African American; Agreement; Authorship; Biological Markers; Capital; Caring; Child; Childhood; Chronic Fatigue Syndrome; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Contracts; Data Collection; Degree program; Department chair; Development; Development Plans; Discipline; Drug resistance; Effectiveness; Ensure; Ethnic group; Faculty; Fellowship; Fund Raising; Future; Health; Health system; Hispanics; Infrastructure; Institution; Institutional Review Boards; International; Interview; Knowledge; Lead; Leadership; Letters; Mentors; Minority Groups; Mission; Movement Disorders; Multiple Sclerosis; Municipal Hospitals; Neurologic; Neurologist; Neurology; Neuromuscular Diseases; Neuropsychology; Neurosciences; Neurosciences Research; New York City; Ophthalmology; Outcome; Outcomes Research; Participant; Patients; Pediatric Neurology; Persons; Population; Population Heterogeneity; Positioning Attribute; Protocols documentation; Publications; Publishing; Quality of life; Records; Research; Research Infrastructure; Research Personnel; Residencies; Resources; Scholarship; Schools; Seasons; Services; Site; Societies; South Asian; Spinal cord injury; Standardization; Testing; Therapy trial; Time; Training; Training Programs; Translating; Underinsured; Visit; Woman; career; certificate program; childhood epilepsy; data quality; ethnic diversity; evidence base; experience; faculty research; graduate medical education; improved; investigator-initiated trial; medical schools; multi-ethnic; nervous system disorder; neuro-oncology; neuroAIDS; neurological rehabilitation; neuropathology; novel therapeutics; outreach; patient population; professor; programs; protocol violation; racial diversity; recruit; research study; skills; socioeconomics; training opportunity; translational neuroscience

Well-designed clinical trials are necessary in order to effectively test the best evidence-based, biomarker informed when possible, therapies to persons living with neurological conditions. However, these can be challenging to implement when resources are fragmented and when a condition is so rare that single center recruitment is not possible. The Icahn School of Medicine at Mount Sinai (ISMMS) NeuroNEXT team supports the notion that in order to translate the best neurological evidence, it is necessary to minimize duplication of efforts by increasing collaboration with stakeholders across multiple conditions, disciplines and centers. Rationale: The Department of Neurology and collaborators at the ISMMS have the trialists, related expertise (e.g. neuroradiology, neuro-psychology, neurorehabilitation, neuropathology, biomarker and health outcomes/disparities research), clinical trials research infrastructure, large and diverse population and local and institutional leadership support to be a new, successful, and actively contributing NeuroNEXT site. Aims: We are committed to collaborating in conducting at least 4 trials of therapies (as required by NeuroNEXT) that have the potential to improve the lives of persons with neurological conditions and to utilize a central IRB and standardized master contract agreement. With access to a large population of highly diverse socio-economic strata across multiple boroughs of New York City and beyond, Mount Sinai NeuroNEXT team will lead and support trials across a broad range of conditions, in both pediatric and adult populations, and will train and mentor at least 2-3 junior investigators to become future clinical trials leaders in neurology. We will share knowledge (bi-directionally) about effective practices in recruitment, retention and outreach with other sites around the US and will actively engage in network workgroups and committees, to strengthen the impact of the research. Expected outcomes: Ultimately, Mount Sinai NeuroNEXT, committed to participate collaboratively and effectively in testing of the new therapies, will contribute to trials aimed at improving quality of life and outcomes in children and adults afflicted by a neurological condition. Mount Sinai NeuroNEXT will also contribute to the training of junior investigators who will become future clinical trialists.

精心设计的临床试验是必要的，以便有效地测试针对神经系统疾病患者的最佳循证、生物标记物的治疗方法。然而，当资源分散且情况非常罕见以至于不可能进行单一中心招募时，这些实施起来可能具有挑战性。西奈山伊坎医学院 (ISMMS) NeuroNEXT 团队支持这样一种观点，即为了转化最好的神经学证据，有必要通过加强与跨多个条件、学科和中心的利益相关者的合作来最大程度地减少重复工作。 理由：ISMMS 的神经病学系和合作者拥有试验人员、相关专业知识（例如神经放射学、神经心理学、神经康复、神经病理学、生物标志物和健康结果/差异研究）、临床试验研究基础设施、大量多样化的人口以及当地和机构领导支持成为一个新的、成功的、积极贡献的 NeuroNEXT 网站。 目标：我们致力于合作进行至少 4 项疗法试验（根据 NeuroNEXT 的要求），这些试验有可能改善神经系统疾病患者的生活，并利用中央 IRB 和标准化主合同协议。通过接触纽约市及其他地区多个行政区的大量高度多样化的社会经济阶层人口，西奈山 NeuroNEXT 团队将领导和支持针对儿童和成人等广泛病症的试验，并将培训和支持指导至少 2-3 名初级研究人员成为未来神经病学临床试验的领导者。我们将与美国各地的其他网站（双向）分享有关招聘、保留和推广方面有效实践的知识，并将积极参与网络工作组和委员会，以加强研究的影响。 预期结果：最终，西奈山 NeuroNEXT 致力于有效地协作参与新疗法的测试，将为旨在改善患有神经系统疾病的儿童和成人的生活质量和结果的试验做出贡献。西奈山 NeuroNEXT 还将为培训将成为未来临床试验人员的初级研究人员做出贡献。