Mount Sinai Network of Excellence in Neuroscience Clinical Trials

设计良好的临床试验是必要的，以便有效地测试最好的基于证据的、在可能的情况下告知生物标记物的对患有神经疾病的人的治疗方法。然而，当资源支离破碎，当情况如此罕见，以至于无法进行单中心招聘时，这些措施的实施可能会具有挑战性。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，有必要通过加强与多个条件、学科和中心的利益相关者的合作，将重复工作降至最低。理论基础：ISMMS的神经病学系和合作者拥有试验者、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、生物标记物和健康结果/差异研究)、临床试验研究基础设施、庞大和多样化的人口以及当地和机构的领导支持，以成为一个新的、成功的和积极贡献的NeuroNEXT网站。目标：我们致力于合作进行至少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团队可以接触到纽约市多个行政区和其他地区的大量高度多样化的社会经济阶层，他们将领导和支持各种条件下的儿童和成人试验，并将培训和指导至少2-3名初级研究人员，使其成为未来神经学临床试验的领导者。我们将与美国各地的其他网站分享在招聘、保留和拓展方面的有效做法的知识(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。预期结果：最终，西奈山NeuroNEXT致力于合作和有效地参与新疗法的测试，将为旨在改善患有神经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还将有助于培训初级研究人员，他们将成为未来的临床试验人员。

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.