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.

Leadership, investigators, and staff of Mount Sinai NeuroNEXT have the skills and experience and are committed to collaborating in the conduct of trials of therapies that have the potential to improve the lives of persons with neurological conditions. With access to a large population of highly diverse socioeconomic strata and across multiple boroughs of New York City and beyond, Mount Sinai NeuroNEXT investigators will lead and support clinical trials across a broad range of conditions and in both pediatric and adult populations, and will train junior investigators to become future clinical trials leaders in neurology. We will also share knowledge about best practices in recruitment, retention and outreach with other sites around the US and will actively engage in network leadership activities to help strengthen the effectiveness and impact of the research.