Mount Sinai Network of Excellence in Neuroscience Clinical Trials

精心设计的临床试验是必要的，以便在可能的情况下有效地测试以证据为基础的最佳生物标志物治疗方法。然而，当资源分散时，当一种情况非常罕见，不可能进行单一中心招聘时，这些方法的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，即为了转化最佳的神经学证据，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，最大限度地减少重复工作。理由：ISMMS的神经学系和合作者拥有试验人员、相关专业知识（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、庞大而多样化的人口以及当地和机构领导的支持，以成为一个新的、成功的、积极贡献的NeuroNEXT站点。目标：我们致力于合作开展至少4项治疗试验（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和标准化的主合同协议。西奈山NeuroNEXT团队将在纽约市及其他地区的多个区领导和支持各种条件下的临床试验，包括儿科和成人人群，并将培训和指导至少2-3名初级研究人员，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（双向）分享有关招聘、保留和推广的有效实践的知识，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，Mount Sinai NeuroNEXT致力于合作并有效地参与新疗法的测试，将有助于改善儿童和成人神经系统疾病患者的生活质量和预后。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。

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.