Wake Forest NeuroNext Clinical Site (WAKENN)
Wake Forest NeuroNext Clinical Site (WAKENN)
批准号:
10744928
负责人:
Mustapha Ahmad Ezzeddine
金额:
$42.63万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-15 至 2028-08-31
关键词:
AdultAlabamaAlzheimer&aposs DiseaseAlzheimer&aposs Disease Core CenterAmericanAwardBaptist ChurchCapsicumCaringCell TherapyChildhoodClinicalClinical ResearchClinical SciencesClinical TrialsCohort StudiesCollaborationsConduct Clinical TrialsCountryDataData Coordinating CenterDedicationsDevelopmentDistrict of ColumbiaEconomically Deprived PopulationEnrollmentEnsureEthnic OriginFacultyFellowshipFellowship ProgramFemaleFundingFutureGene therapy trialGeneral PractitionersGeographyGoalsGrowthHealthHealth SciencesHealth systemHeart AtriumHispanicHomeHospitalsIncentivesInfrastructureInstitutionInterdisciplinary StudyLeadLeadershipLearningLocationMentorsMentorshipMinority EnrollmentMissionMulti-Institutional Clinical TrialNeurologistNeurologyNeurosciencesNorth CarolinaOccupational activity of managing financesParticipantPatient CarePatientsPediatric HospitalsPediatric NeurologyPerformancePersonsPopulation HeterogeneityPositioning AttributeProceduresProcessProtocols documentationPublic HealthRare DiseasesRegenerative MedicineReportingReproducibilityResearchResearch DesignResearch InfrastructureResearch PersonnelResourcesSecureSiteSolidSouth CarolinaSoutheastern United StatesSpecialistSpecimenSystemTherapeutic StudiesTrainingTraining ProgramsTranslational ResearchUnderrepresented PopulationsUnderserved PopulationUnited StatesUniversitiesWomancareercareer developmentclinical epidemiologyclinical research siteclinical trial participantdata integritydata managementdesigndrug discoveryexperienceforestgene therapyimprovedinfrastructure developmentmedical schoolsminority patientmultidisciplinarynervous system disordernext generationnovel strategiesorganizational structureoutreachparticipant enrollmentpatient retentionpeerpre-clinicalprogramsrecruitremote consentsenior facultysocioeconomic disadvantagesuccesstranslational pipelinetranslational scientist
中文摘要
中庭健康维克森林浸信会(AHWFB)自2018年以来一直是NeuroNEXT临床站点(WAKENN)。在我们最初的资助期间,WAKENN一直是NeuroNEXT网络(NN)的强大贡献者。我们已经迅速启动了这5年内可用的3项神经网络研究。我们一直是高注册用户(N=19)--甚至被要求停止在NN110注册,以“让其他站点有机会注册”。登记参与者的多样性表明我们有能力招募代表人数不足的人群;58%的人是女性、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)。与其他网络站点相比,我们的其他性能指标也高于平均水平。WAKENN有一个充满活力的友谊。WAKENN的一个独特成功是推出了Wake Investigator Network Development(WIND),以支持NN研究员加强培训和联网,进行多学科合作,以推进临床研究和临床试验。三名研究员(到目前为止)已经完成了奖学金计划;两名研究员获得了独立研究资金。在这一资助期间,由于我们与Atrium Health(现在有40家医院的医疗系统)的合作伙伴关系,WAKENN的临床足迹有了相当大的增长。这为合作、传播和接触代表性不足的患者以及接触多学科调查人员提供了新的机会。我们现在有两家儿童医院,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,有超过350万的集水区。我们在基因治疗方面拥有临床经验,积极参与基因治疗试验,并在基因治疗药物发现方面拥有临床前专业知识。我们的成功得益于我们敬业的领导(Ezzeddine、Strowd、Duncan、Munger Clary)和忠诚的团队(Sissine、Burgos),并得到了我们部门、机构和整个中庭健康系统的坚定承诺的支持,该系统将WAKENN视为企业范围内的优先事项。这得到了坚实的机构承诺的支持,即在资源需求出现时满足这些需求。我们已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又一个成功的资助期。我们将实现以下目标:目标1:继续利用我们的地理、种族和经济多元化的集水区,有效地招募和留住来自历史上服务不足的人群的临床试验参与者。目标2:在我们扩大的卫生事业中使用和整合临床试验扩展基础设施,以促进罕见和超罕见疾病的NN试验。目标3:利用我们综合学术卫生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、增长和实施。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和可重复的试验。
英文摘要
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.
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会议论文
NINDS Stroke Trials Network - Regional Coordinating Center
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批准号:8739334
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项目类别:
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资助金额:$38.0万
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财政年份:2013
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负责人:Mustapha Ahmad Ezzeddine
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依托单位:
NINDS Stroke Trials Network - Regional Coordinating Center
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批准号:8895432
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项目类别:
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资助金额:$18.6万
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财政年份:2013
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负责人:Mustapha Ahmad Ezzeddine
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依托单位:
NINDS Stroke Trials Network - Regional Coordinating Center
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批准号:8661881
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项目类别:
-
资助金额:$38.0万
-
财政年份:2013
-
负责人:Mustapha Ahmad Ezzeddine
-
依托单位:
NINDS Stroke Trials Network - Regional Coordinating Center
-
批准号:9118354
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项目类别:
-
资助金额:$38.0万
-
财政年份:2013
-
负责人:Mustapha Ahmad Ezzeddine
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依托单位:
海外基金