Wake Forest NeuroNext Clinical Site (WAKENN)

维克森林 NeuroNext 临床站点 (WAKENN)

基本信息

批准号：
10744928
负责人：
Mustapha Ahmad Ezzeddine
金额：
$ 42.63万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-15 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10744928
关键词：
Adult Alabama Alzheimer&apos s Disease Alzheimer&apos s Disease Core Center American Award Baptist Church Capsicum Caring Cell Therapy Childhood Clinical Clinical Research Clinical Sciences Clinical Trials Cohort Studies Collaborations Conduct Clinical Trials Country Data Data Coordinating Center Dedications Development District of Columbia Economically Deprived Population Enrollment Ensure Ethnic Origin Faculty Fellowship Fellowship Program Female Funding Future Gene therapy trial General Practitioners Geography Goals Growth Health Health Sciences Health system Heart Atrium Hispanic Home Hospitals Incentives Infrastructure Institution Interdisciplinary Study Lead Leadership Learning Location Mentors Mentorship Minority Enrollment Mission Multi-Institutional Clinical Trial Neurologist Neurology Neurosciences North Carolina Occupational activity of managing finances Participant Patient Care Patients Pediatric Hospitals Pediatric Neurology Performance Persons Population Heterogeneity Positioning Attribute Procedures Process Protocols documentation Public Health Rare Diseases Regenerative Medicine Reporting Reproducibility Research Research Design Research Infrastructure Research Personnel Resources Secure Site Solid South Carolina Southeastern United States Specialist Specimen System Therapeutic Studies Training Training Programs Translational Research Underrepresented Populations Underserved Population United States Universities Woman career career development clinical epidemiology clinical research site clinical trial participant data integrity data management design drug discovery experience forest gene therapy improved infrastructure development medical schools minority patient multidisciplinary nervous system disorder next generation novel strategies organizational structure outreach participant enrollment patient retention peer pre-clinical programs recruit remote consent senior faculty socioeconomic disadvantage success translational pipeline translational scientist

项目摘要

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.

自2018年以来，Aatrium Health Wake Forest Baptist（AHWFB）一直是神经元网站（“ Wakenn”）。在我们最初的资金中，Wakenn一直是Neuronext网络（NN）的强大贡献者。我们已经迅速启动了在这5年期间可用的3个NN研究。我们一直是一个很高的入学者（n = 19） - 甚至被要求停止在NN110入学到“让其他网站有机会的机会多样化，这表明我们有能力招募缺乏代表性的人群； 58％的女性，非白人或西班牙裔族裔是女性，而36％的妇女是妇女，以及21％的妇女，以及以上是5％的人，是5％的人，我们的态度是5％，我们的态度是5％的，我们的态度是5％的）。其他网站。与中庭健康（现在是40个医院卫生系统）的合作伙伴关系。现在，我们有两家儿童医院，布伦纳和莱文儿童医院（LCH）。 LCH是亚特兰大和华盛顿特区之间最大的儿童医院，流域超过350万。我们在基因疗法，积极参与基因治疗试验以及基因治疗药物发现方面具有临床专业知识。我们的成功是因为我们敬业的领导力（Ezzeddine，Strowd，Duncan，Munger Clary）和犯人团队（Sissine，Burgos），并获得了我们部门，机构和整个Atrium Health System的坚定承诺，这将Wakenn视为企业范围内的优先事项。这是有坚实的机构承诺，以满足资源需求的产生。我们建立和积极的组织结构，我们的专业知识和机构承诺将确保另一个成功的基础时期。我们将达到以下目标：目标1：继续利用我们的地理，种族和经济多样化的集水区，以有效地招募和保留来自历史悠久服务不足人群的临床试验参与者。目标2：在我们扩大的健康企业中采用和整合临床试验外展基础设施，以促进稀有和超稀有疾病NN试验。目标3：利用我们综合的学术健康企业的临床研究资源来激励，协调和透明地跟踪临床试验创建，成长和实施。目标4：继续招募和培训下一代神经科学研究人员，以设计和实施有意义的和复制的试验。