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.

AAtrium Health Wake Forest Baptist (AHWFB) 自 2018 年以来一直是 NeuroNEXT 临床中心（“WAKENN”）。在我们的初始资助期间，WAKENN 一直是 NeuroNEXT 网络 (NN) 的强大贡献者，我们已迅速启动了 3 项 NN 研究。在这 5 年期间，我们的注册人数一直很高（N=19），甚至被要求停止 NN110 的注册，以“让其他站点有机会注册”。注册参与者的多样性表明我们有能力招募代表性不足的人群；58% 是女性、非白人或西班牙裔（例如 36% 是女性，21% 是非白人，5% 是西班牙裔）。与其他网站相比，WAKENN 拥有充满活力的奖学金，WAKENN 的一个独特成功是推出了 Wake 调查员网络开发 (WIND)，以支持 NN 研究员加强多学科培训和网络建设。合作推进临床研究和临床试验。三名研究员（迄今为止）已经完成了研究金计划；两名研究员获得了独立研究资金。在此资助期间，由于我们与 Atrium Health 的合作（现已达到 40 家），WAKENN 的临床足迹显着增长。 -医院卫生系统）。这为代表性不足的患者和接触多学科研究人员的合作、传播和外展提供了新的机会，即布伦纳儿童医院和莱文儿童医院（LCH）。 LCH 是亚特兰大和华盛顿特区之间最大的儿童医院，服务对象超过 350 万，我们拥有基因治疗的临床经验、积极参与基因治疗试验以及基因治疗药物发现的临床前专业知识。我们敬业的领导层（Ezzeddine、Strowd、Duncan、Munger Clary）和忠诚的团队（Sissine、Burgos），并得到我们部门、机构和整个 Atrium Health 系统的坚定承诺的支持，WAKENN作为整个企业的优先事项，我们建立了积极的组织结构，我们的专业知识和机构承诺将确保我们将实现以下目标：目标 1：继续利用我们在地理、种族和经济方面的多元化优势，有效地招募和留住历史上服务不足的人群中的临床试验参与者。目标 2：在我们扩大的医疗企业中利用和整合临床试验基础设施，以促进稀有和超大规模的临床试验。 -罕见疾病 NN 试验。 3：利用我们综合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的创建、发展和实施。目标 4：继续招募和培训下一代神经科学研究人员来设计和实施。有意义且可重复的试验。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Letter regarding "Seizure control in women with epilepsy undergoing assisted reproductive technology".

关于“接受辅助生殖技术的癫痫女性癫痫发作控制”的信函。

DOI：
发表时间：
2024-04
期刊：
影响因子：
5.6
作者：
Decker, Barbara M;Clary, Heidi Munger;Holmes, Manisha G;Al;Esmaeili, Behnaz;Waldman, Genna;Becker, Danielle A;Johnson, Julia;Voinescu, Paula E;Gerard, Elizabeth E;Assisted Reproductive Technology/In Vitro Fertilization Committee o
通讯作者：
Assisted Reproductive Technology/In Vitro Fertilization Committee o