Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites)
Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites)
批准号:
10744306
负责人:
TRACY A GLAUSER
金额:
$46.02万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
未结题
起止时间:
2018-07-01 至 2028-06-30
关键词:
AdultAffectAgreementApplications GrantsAwardBiological MarkersCareer MobilityCaringChildhoodClinicalClinical InvestigatorClinical ResearchClinical TrialsClinical Trials NetworkCollaborationsCommunitiesCommunity OutreachComplementConduct Clinical TrialsCountryDataDevelopmentEducationEthnic OriginFoundationsFundingFutureGenderGene therapy trialGenerationsGoalsHealthInfrastructureInstitutionInstitutional Review BoardsInternationalLeadLeadershipLettersLocationMedical centerMedicineMinority GroupsModelingNational Institute of Neurological Disorders and StrokeNetwork InfrastructureNeurologyNeurosciencesParticipantPatient RecruitmentsPatientsPediatric HospitalsPersonsPhase III Clinical TrialsPopulationPredispositionPreparationProductivityProtocols documentationPublicationsRaceRandomizedResearchResearch DesignResearch InfrastructureResearch PersonnelRoleSecureSiteSpecialistStandardizationTestingTrainingUnited States National Institutes of HealthUniversitiesage relatedcareer developmentclinical biomarkersclinical research sitecommunity engagementdesignepidemiology studyequity, diversity, and inclusionexperiencegenetic epidemiologyimplementation facilitationimprovedinnovationmembernervous system disordernovel therapeuticsoutreach programpatient populationphase II trialprogramsrecruitresearch studysexskillssuccesswillingness
中文摘要
CincNEXT是独立的辛辛那提儿童医院医疗中心(CCHMC)和辛辛那提大学(UC)之间的独特合作,旨在继续成为NINDS资助的神经科学临床试验卓越网络(NeuroNEXT)网络中的一个富有成效的临床网站。拟议申请的目的是确保所需的基础设施支持,以保持CincNEXT网站在第一和第二支持周期中为Next Network进行的出色临床试验的质量。CincNEXT的具体目标是促进NeuroNEXT网络研究的实施、增强招聘、最大限度地保留和优化研究进行。第二个目标是通过参与网络治理、网络委员会和网络活动,积极为NeuroNEXT网络的整体成功做出贡献。第三个目标是实施新的/初级研究员职业发展计划,帮助他们发展技能和经验,以参与和/或领导未来的NeuroNEXT和其他NINDS试验。这些目标将通过我们经验丰富的CincNEXT领导团队(两名联合PI和一名全职研究协调员,具有超过9年的NeuroNEXT工作经验)、热情的研究合作者、现有的优秀研究基础设施(包括CTSA)、强大的可参与试验的患者的广度和深度以及两个支持性研究管理部门的共同努力来实现。这两家机构都通过同意继续使用标准化的主试验协议并采用一级集中IRB审查来表明他们对NeuroNEXT网络的承诺。CincNEXT临床网站预计将继续为NeuroNEXT网络试验提供出色的招募、保留和质量,从而推动神经疾病的治疗。CincNEXT建议成为NINDS网络中的关键合作伙伴,该网络提供了强大、标准化和可访问的基础设施,以促进影响成人和儿童人口的神经疾病方案的快速开发和实施。
英文摘要
CinciNEXT is a unique collaboration between the free-standing Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati (UC) that aims to continue to be a productive clinical site in the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) network. The objective of the proposed application is to secure the infrastructural support needed to maintain the outstanding quality of clinical trials that the CinciNEXT site has conducted for the NEXT Network during the first and second cycles of support. Specific goals of CinciNEXT are to facilitate the implementation, enhance recruitment, maximize retention, and optimize study conduct of NeuroNEXT network studies. A second goal is to actively contribute to the overall success of the NeuroNEXT network by participating in network governance, network committees, and network activities. The third goal is to implement a new/junior investigator career advancement program to help them develop skills and experience to participate and/or lead future NeuroNEXT and other NINDS trials. These goals will be achieved by the combination of our experienced CinciNEXT leadership team (two co-PIs and one fulltime research study coordinator with over 9 years of NeuroNEXT experience working together), enthusiastic research collaborators, existing outstanding research infrastructure (including a CTSA), robust breadth and depth of patients available to participate in trials, and two supportive research administrations. Both institutions have shown their commitment to the NeuroNEXT Network by agreeing to continue to use a standardized Master Trial Agreement and employ a Tier 1 level of centralized IRB review. The CinciNEXT clinical site anticipates continuing to provide outstanding recruitment, retention, and quality for NeuroNEXT network trials, and thereby advancing treatments for neurological disorders. CinciNEXT proposes to be a key partner in this NINDS network that has provided a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations.
期刊论文(5)
专著(0)
科研奖励(0)
会议论文
DOI:
10.1097/md.0000000000028645
发表时间:
2022-01-21
期刊:
Medicine
影响因子:
1.6
作者:
[Sawyer RP, Hill EJ, Yokoyama J, Medvedovic M, Ren Y, Zhang X, Choubey D, Shatz RS, Miller B, Woo D]
通讯作者:
Woo D
DOI:
10.1111/epi.16984
发表时间:
2021-09
期刊:
Epilepsia
影响因子:
5.6
作者:
[]
通讯作者:
DOI:
10.1016/j.conctc.2021.100821
发表时间:
2021-09
期刊:
Contemporary clinical trials communications
影响因子:
1.5
作者:
[Lowenhaupt S, Molloy A]
通讯作者:
Molloy A
Clinical Pharmacology K12 Training Program
-
批准号:10749592
-
项目类别:
-
资助金额:$29.7万
-
财政年份:2023
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:10166966
-
项目类别:
-
资助金额:$30.45万
-
财政年份:2018
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:10593621
-
项目类别:
-
资助金额:$29.95万
-
财政年份:2018
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:8869050
-
项目类别:
-
资助金额:$25.55万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:9293406
-
项目类别:
-
资助金额:$31.15万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:8721489
-
项目类别:
-
资助金额:$31.15万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
T32 Cincinnati Pediatric Clinical Pharmacology Training Program
-
批准号:10631893
-
项目类别:
-
资助金额:$16.11万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:8337819
-
项目类别:
-
资助金额:$31.0万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:8241271
-
项目类别:
-
资助金额:$32.43万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:8532063
-
项目类别:
-
资助金额:$30.81万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
Cincinnati Neuroscience Clinical Trials Research Center (CinciNEXT)
-
批准号:9102277
-
项目类别:
-
资助金额:$31.15万
-
财政年份:2011
-
负责人:TRACY A GLAUSER
-
依托单位:
CHILDHOOD ABSENCE EPILEPSY
-
批准号:7607762
-
项目类别:
-
资助金额:$8.08万
-
财政年份:2007
-
负责人:TRACY A GLAUSER
-
依托单位:
CHILDHOOD ABSENCE EPILEPSY
-
批准号:7374540
-
项目类别:
-
资助金额:$6.2万
-
财政年份:2005
-
负责人:TRACY A GLAUSER
-
依托单位:
CHILDHOOD ABSENCE EPILEPSY
-
批准号:7203798
-
项目类别:
-
资助金额:$0.18万
-
财政年份:2004
-
负责人:TRACY A GLAUSER
-
依托单位:
Childhood Absence Epilepsy Rx, PK-PD-Pharmacogenetics
-
批准号:7191606
-
项目类别:
-
资助金额:$311.93万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
Childhood Absence Epilepsy Rx, PK-PD-Pharmacogenetics
-
批准号:7941427
-
项目类别:
-
资助金额:$200.0万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
Impact of Initial Therapy and Response on Long Term Outcome in Children with CAE
-
批准号:8006938
-
项目类别:
-
资助金额:$324.66万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
Childhood Absence Epilepsy Rx, PK-PD-Pharmacogenetics
-
批准号:6805856
-
项目类别:
-
资助金额:$417.01万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
Blood Genomics of Anticonvulsant Efficacy in Children
-
批准号:6777476
-
项目类别:
-
资助金额:$15.37万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
Childhood Absence Epilepsy Rx, PK-PD-Pharmacogenetics
-
批准号:7350189
-
项目类别:
-
资助金额:$645.19万
-
财政年份:2003
-
负责人:TRACY A GLAUSER
-
依托单位:
海外基金