Mount Sinai Network of Excellence in Neuroscience Clinical Trials

设计良好的临床试验是必要的，以有效地测试最好的循证，生物标志物通知时，与神经系统疾病的人的治疗。然而，当资源分散时，以及当疾病非常罕见以至于单中心招募不可能时，这些实施可能具有挑战性。西奈山伊坎医学院（ISMMS）NeuroNEXT团队支持这样一种观点，即为了翻译最好的神经学证据，有必要通过增加与多个条件，学科和中心的利益相关者的合作来减少重复工作。 基本原理：神经病学系和合作者在ISMMS有试验者，相关的专业知识（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，大型和多样化的人口和地方和机构的领导支持是一个新的，成功的，积极贡献NeuroNEXT网站。 目的：我们致力于合作进行至少4项有可能改善神经系统疾病患者生活的治疗试验（根据NeuroNEXT的要求），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多个行政区的大量高度多样化的社会经济阶层，Mount Sinai NeuroNEXT团队将领导和支持在儿童和成人人群中进行的广泛条件下的试验，并将培训和指导至少2-3名初级研究者，使其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分享有关招聘，保留和推广的有效做法的知识（双向），并将积极参与网络工作组和委员会，以加强研究的影响。 预期成果：最终，西奈山NeuroNEXT致力于合作和有效地参与新疗法的测试，将有助于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。Mount Sinai NeuroNEXT还将有助于培训将成为未来临床试验者的初级研究人员。

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.