Wake Forest NeuroNext Clinical Site (WAKENN)

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AAtrium Health Wake Forest Baptist (AHWFB) has been a NeuroNEXT clinical site (“WAKENN”) since 2018. During our initial funding, WAKENN has been a consistently strong contributor to the NeuroNEXT Network (NN). We have rapidly launched the 3 NN studies available during this 5-year period. We have been a high enroller (N=19) – even being asked to stop enrollment in NN110 to “let other sites have the opportunity to enroll”. Diversity of enrolled participants demonstrates our ability to recruit underrepresented populations; 58% were either female, non-white or Hispanic ethnicity (e.g. 36% were women, 21% were non-white, and 5% were Hispanic). Our other performance metrics are also above average compared to other network sites. WAKENN has a vibrant fellowship. A unique success for WAKENN was the launch of the Wake Investigator Network Development (WIND) to support NN fellows in enhanced training and networking for multi- disciplinary collaboration to advance clinical research and clinical trials. Three fellows (to date) have completed the fellowship program; two have secured independent research funding. During this funding period, the WAKENN clinical footprint has grown considerably because of our partnership with Atrium Health (now 40-hospital health system). This offers new opportunities for collaboration, dissemination, and outreach to underrepresented patients and access to multidisciplinary investigators. We now have two children's hospitals, Brenner’s and Levine Children's Hospital (LCH). LCH is the largest children's hospital between Atlanta and Washington DC, with a catchment of more than 3.5 million. We have clinical experience with gene therapy, active participation in gene therapy trials, and preclinical expertise in gene therapy drug discovery. Our success is because of our dedicated leadership (Ezzeddine, Strowd, Duncan, Munger Clary) and committed team (Sissine, Burgos) and is backed with strong commitments from our department, institution, and the entire Atrium Health system which sees WAKENN as an enterprise-wide priority. This is backed with a solid institutional commitment to meet resource needs as they arise. Our established and active organizational structure, our expertise, and institutional commitment will ensure another successful funding period. We will meet the following aims: AIM 1: To continue to leverage our geographically, ethnically, and economically diverse catchment to effectively enroll and retain clinical trial participants from historically underserved populations. AIM 2: To employ and integrate clinical trial outreach infrastructure across our expanded health enterprise to promote rare and ultra-rare disease NN trials. AIM 3: To leverage the clinical research resources of our integrated academic health enterprise to incentivize, coordinate, and transparently track clinical trial creation, growth, and implementation. AIM 4: To continue to recruit and train the next generation of neuroscience researchers to design and implement meaningful and reproducible trials.