Neonatal Research Network Data Coordinating Center (DCC) 2023-2028
新生儿研究网络数据协调中心 (DCC) 2023-2028
基本信息
- 批准号:10833754
- 负责人:
- 金额:$ 200万
- 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
- 起止时间:2018-04-01 至 2030-03-31
- 项目状态:未结题
- 来源:
- 关键词:AddressBiometryChildhoodClinical ResearchClinical TrialsClinical Trials NetworkCollaborationsCommunicationDataData AnalysesData CollectionData Coordinating CenterData Management ResourcesData ScienceDevelopmentEnrollmentEnsureFeasibility StudiesFundingFutureGenomicsGoalsHelping to End Addiction Long-termHuman ResourcesHybridsInfant DevelopmentInformaticsInfrastructureInternationalKnowledgeLeadershipLettersMasksMilrinoneMonitorMulticenter Neonatal Research NetworkMulticenter StudiesNational Institute of Child Health and Human DevelopmentNeonatalNetwork InfrastructureNewborn InfantOccupational activity of managing financesPopulation HeterogeneityPositioning AttributePrincipal InvestigatorProcessProductivityProtocols documentationPublicationsPublishingQualifyingReportingReproducibilityResearchResearch DesignResearch PersonnelResearch PriorityResourcesRoleRunningSafetySecureSiteStandardizationStatistical Data InterpretationStatistical MethodsStructureSystemTrainingTreatment EfficacyUnited States Food and Drug AdministrationUnited States National Institutes of HealthWeaningWorkclinical centerclinical practiceclinical research sitecomputer programdata managementdata qualitydata sharingdesignevidence baseexperienceflexibilityhealth economicsinnovationmultidisciplinaryneonatal careneonateoperationparticipant safetypatient safetyprogramsrandomized trialsuccesstooltrial designvision development
项目摘要
PROJECT SUMMARY/ABSTRACT
Critical gaps in neonatal research require multicenter involvement and innovative designs to study them.
NICHD views the next chapter of its Neonatal Research Network (NRN) as its “primary and first-line
infrastructure” for conducting definitive, rigorous, and reproducible multicenter clinical research in newborns
that generates evidence to guide clinical practice. There is a crucial need for an independent Data
Coordinating Center (DCC) to provide sophisticated and impartial biostatistical and operational expertise that
helps the NRN target its resources and optimize its scientific impact by (1) helping identify research topics of
high priority, (2) providing objective statistical expertise for the design and analyses of rigorous and feasible
studies, (3) developing processes and systems to increase efficiencies and optimize effective usage of
limited resources through external partnerships that amplify the NRN scientific goals, (4) ensuring
standardization of study design, development, data collection and analyses, and (5) disseminating results.
RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 7 years. We
will maximize the scientific impact of the NRN by (1) collaborating in the development of rigorous and
innovative trial designs and statistical methods to address the unique challenges in neonatal research; (2)
optimizing productivity by providing flexible and efficient data/project management and study monitoring, and
promote data sharing, integration, and harmonization; (3) vigorously pursuing external partnerships to
support and amplify NRN scientific goals; (4) protecting participant safety and study integrity; (5) providing
timely data analysis and collaborative dissemination for all NRN studies; and (6) providing the logistical,
communications, and regulatory support necessary to run an efficient and productive multicenter clinical
research network. Dr. Abhik Das, the proposed PI, has extensive experience in neonatal clinical studies,
leading the NRN DCC for the past 17 years. He will be assisted by Alternate PI, Dr. Carla Bann, and staff
with significant NRN experience. This application has unique strengths to help advance the NRN research
agenda: (1) a highly qualified and motivated PI and staff with in-depth knowledge and years of experience in
neonatal research needs, enabling seamless continuation of NRN research without additional training or
resources; (2) proven track record of scientific productivity documented in the quality and quantity of NRN
studies and publications supported by RTI that have changed clinical practice, and leveraging the NRN
infrastructure to advance NICHD and NRN scientific goals; (3) a state-of-the-art infrastructure of tools,
processes, and systems that are flexible and customized to the needs of the NRN; (4) multidisciplinary
experts who can collaborate with NRN Investigators to realize research goals; (5) robust data management
systems customized for the NRN that ensure data quality; and (6) an agile administrative structure providing
maximum flexibility in staffing and contractual operations to respond quickly to changing NRN needs.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Abhik Das其他文献
Abhik Das的其他文献
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{{ truncateString('Abhik Das', 18)}}的其他基金
Neonatal Research Network Data Coordinating Center (DCC) 2023-2028
新生儿研究网络数据协调中心 (DCC) 2023-2028
- 批准号:
10879205 - 财政年份:2023
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)
数据协调中心 (DCC) 新生儿阿片类药物戒断综合征药物治疗比较有效性试验 (NOWS PhaCET)
- 批准号:
10491217 - 财政年份:2021
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)
数据协调中心 (DCC) 新生儿阿片类药物戒断综合征药物治疗比较有效性试验 (NOWS PhaCET)
- 批准号:
10378283 - 财政年份:2021
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)
数据协调中心 (DCC) 新生儿阿片类药物戒断综合征药物治疗比较有效性试验 (NOWS PhaCET)
- 批准号:
10678679 - 财政年份:2021
- 资助金额:
$ 200万 - 项目类别:
Archiving and Documenting Data from the NICHD Neonatal Research Network
归档和记录来自 NICHD 新生儿研究网络的数据
- 批准号:
9803847 - 财政年份:2019
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center for the NICHD Neonatal Research Network (U24)
NICHD 新生儿研究网络数据协调中心 (U24)
- 批准号:
10375431 - 财政年份:2018
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center for the NICHD Neonatal Research Network (U24)
NICHD 新生儿研究网络数据协调中心 (U24)
- 批准号:
9983354 - 财政年份:2018
- 资助金额:
$ 200万 - 项目类别:
Transfusion of Prematurity Early School Age Follow-up (TOP 5) DCC
早产儿输血早期学龄随访(TOP 5)DCC
- 批准号:
10021687 - 财政年份:2018
- 资助金额:
$ 200万 - 项目类别:
Transfusion of Prematurity Early School Age Follow-up (TOP 5) DCC
早产儿输血早期学龄随访(TOP 5)DCC
- 批准号:
10247622 - 财政年份:2018
- 资助金额:
$ 200万 - 项目类别:
Data Coordinating Center for the NICHD Neonatal Research Network (U24)
NICHD 新生儿研究网络数据协调中心 (U24)
- 批准号:
9898399 - 财政年份:2018
- 资助金额:
$ 200万 - 项目类别:
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