Clinical Trials Logistics Core
临床试验物流核心
基本信息
- 批准号:10361406
- 负责人:
- 金额:$ 31.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-03-15 至 2025-02-28
- 项目状态:未结题
- 来源:
- 关键词:AddressAdultApplications GrantsAttentionBehavior DisordersBehavior TherapyBehavioralChildChild Mental DisordersChild WelfareChildhoodClinical TrialsClinical trial protocol documentCommunitiesCommunity ParticipationDataData CollectionEducational workshopEmotionalEmotional disorderEnrollmentEnsureEquipmentEvaluationFacultyFundingGoalsHumanInformed ConsentInfrastructureInstitutional Review BoardsInterventionIntervention StudiesIntervention TrialLife StyleLogisticsMeasurementMeasuresMissionMonitorMonitoring Clinical TrialsOutcomeOutcome StudyParticipantPoliciesPreparationPrevalencePreventionPrevention strategyPrevention trialProcessProtocols documentationPsyche structureReportingReproducibilityResearchResearch PersonnelResearch Project GrantsRisk FactorsSchoolsScientistSecureSeedsServicesSpecific qualifier valueStatistical Data InterpretationTechnical ExpertiseTrainingUnited States National Institutes of HealthUniversitiesWorkYouthbehavioral healthcareerclinical centerclinical practicecommunity engagementdata managementdesignexperiencehigh standardhuman subjectimplementation interventionimplementation processimprovedinnovationinstrumentationmeetingsobesity in childrenpreventive interventionprimary outcomeprospectiveprotocol developmentrecruitresearch clinical testingresearch facilitysecondary endpointsecondary outcomestatisticssuccesstoolunhealthy lifestyle
项目摘要
The prevalence rates for children’s mental, emotional, and behavioral disorders, as well as for childhood
obesity, are at alarmingly high levels and need to be systematically addressed through effective prevention
strategies. Early-stage scientists in the Research Center for Child Well-Being are conducting intensive
prevention trials that are supported in part by the Center’s Clinical Trials Logistics Core research facility (CTL
Core). The CTL Core seeks to bolster the scientific rigor and transparency of the Center’s preventive
intervention clinical trials, which involve the prospective assignment of human participants to an intervention
and evaluate behavioral and health-related outcomes. The CTL Core is essential to ensure compliance with
NIH’s most recent Clinical Trials Policies. Early-stage investigators, central to the Center’s mission and goals,
do not yet have the experience and infrastructure support to incorporate the newest Clinical Trial requirements
into the conceptualization, conduct, and reporting of their intervention trials. The evaluation of interventions for
the prevention and reduction of mental, emotional, behavioral, and unhealthy lifestyle-related risk factors in
childhood requires substantial support and guidance with respect to preparatory steps, community and school
engagement, trial reporting demands, state-of-the-art measurement of primary and secondary outcomes, and
focused evaluation of intervention implementation processes. The CTL Core provides the requisite
infrastructure, instrumentation, and technical expertise to support the prevention trials and related studies
conducted by the early-stage investigators to rigorously implement interventions within real-world settings. The
CTL Core draws on the Center’s local Community Advisory Board and experienced staff to promote effective
community and school engagement. Overall, the CTL Core enhances the integrity of the independent and
dependent variables measured in Center sponsored research by ensuring: state-of-the-art measures; well-
specified and deployed intervention and measurement protocols; and diligent attention to human subjects’
protocols and issues. The CTL Core aims include: AIM 1: Deploy a cogent team to provide technical expertise
and state-of-the-art instrumentation to the Center’s early-stage investigators to conduct high-quality prevention
trials; AIM 2: Provide support and guidance for: (a) the research projects led by Center early-stage
investigators with respect to the preparation, conduct, and reporting of their prevention trials; (b) pilot seed
projects; and, (c) the preparation of R01-level research projects by transitioning early-stage investigators; and
AIM 3: Conduct technical training workshops for early-stage investigators, faculty, and staff in the Center, and
other university faculty who conduct prevention trials involving children, on (1) community participation and
engagement; and (2) requirements, compliance, and best practices for clinical trials. The CTL Core provides
critical support to move investigators to independent researcher status.
儿童精神、情感和行为障碍以及儿童期的患病率
肥胖症,处于惊人的高水平,需要通过有效的预防系统地解决
战略布局儿童福利研究中心的早期科学家正在进行密集的
预防试验,部分由中心的临床试验后勤核心研究设施(CTL)支持
核心)。CTL核心旨在加强该中心预防措施的科学严谨性和透明度,
干预性临床试验,涉及对人类参与者进行干预的前瞻性分配
并评估行为和健康相关的结果。CTL核心对于确保遵守
NIH最新的临床试验政策。早期研究人员是中心使命和目标的核心,
尚未具备纳入最新临床试验要求的经验和基础设施支持
概念化,进行和报告他们的干预试验。对干预措施的评价
预防和减少与精神、情感、行为和不健康生活方式相关的危险因素,
儿童期需要在准备步骤、社区和学校方面得到大量的支持和指导
参与度、试验报告要求、主要和次要结局的最新测量,以及
重点评价干预措施的实施过程。CTL核心提供了必要的
支持预防试验和相关研究的基础设施、仪器和技术专长
由早期研究人员进行,以在现实世界中严格实施干预措施。的
CTL核心利用该中心的当地社区咨询委员会和经验丰富的工作人员,以促进有效的
社区和学校的参与。总的来说,CTL核心增强了独立和
在中心赞助的研究中测量的因变量,确保:最先进的措施;以及-
指定和部署的干预和测量协议;以及对人类受试者的
协议和问题。CTL的核心目标包括:目标1:部署一支有说服力的团队,
和最先进的仪器,以中心的早期调查人员进行高质量的预防
目标2:为以下项目提供支持和指导:(a)由中心领导的早期研究项目
研究者在预防试验的准备、实施和报告方面的知识;(B)中试种子
(c)通过过渡早期研究人员准备R 01级研究项目;以及
目标3:为中心的早期研究人员、教职员工举办技术培训讲习班,
开展涉及儿童的预防试验的其他大学教师,关于(1)社区参与,
参与;(2)临床试验的要求、合规性和最佳实践。CTL核心提供
为调查员晋升为独立研究员提供关键支持。
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)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
MICHAEL W BEETS其他文献
MICHAEL W BEETS的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('MICHAEL W BEETS', 18)}}的其他基金
Behavioral-Biomedical Interface: Translational and Prevention Sciences Training
行为生物医学界面:转化和预防科学培训
- 批准号:
10619806 - 财政年份:2023
- 资助金额:
$ 31.45万 - 项目类别:
A Meta-Epidemiological Assessment of the Role of Pilot Studies in the Design of Well-Powered Trials - the Pilot Project
对试点研究在设计有力试验中的作用进行元流行病学评估 - 试点项目
- 批准号:
9977247 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
利用低收入家庭的经济激励措施减少儿童肥胖的健康差异
- 批准号:
10627850 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
A Meta-Epidemiological Assessment of the Role of Pilot Studies in the Design of Well-Powered Trials - the Pilot Project
对试点研究在设计有力试验中的作用进行元流行病学评估 - 试点项目
- 批准号:
10213827 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
利用低收入家庭的经济激励措施减少儿童肥胖的健康差异
- 批准号:
10418684 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
A Meta-Epidemiological Assessment of the Role of Pilot Studies in the Design of Well-Powered Trials - the Pilot Project
对试点研究在设计有力试验中的作用进行元流行病学评估 - 试点项目
- 批准号:
10435425 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
利用低收入家庭的经济激励措施减少儿童肥胖的健康差异
- 批准号:
10165707 - 财政年份:2019
- 资助金额:
$ 31.45万 - 项目类别:
Etiology of Accelerated Weight Gain during Summer vs. School in Adolescents: What's UP (Undermining Prevention) with Summer 2
青少年夏季体重增加与上学期间体重加速增加的病因学:夏季 2 的 UP(破坏预防)
- 批准号:
10663707 - 财政年份:2018
- 资助金额:
$ 31.45万 - 项目类别:
What's UP (Undermining Prevention) with Summer? Etiology of Accelerated Weight Gain during Summer vs. School Year
夏天有什么 UP(破坏预防)吗?
- 批准号:
10241325 - 财政年份:2018
- 资助金额:
$ 31.45万 - 项目类别:
相似海外基金
Co-designing a lifestyle, stop-vaping intervention for ex-smoking, adult vapers (CLOVER study)
为戒烟的成年电子烟使用者共同设计生活方式、戒烟干预措施(CLOVER 研究)
- 批准号:
MR/Z503605/1 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Research Grant
Early Life Antecedents Predicting Adult Daily Affective Reactivity to Stress
早期生活经历预测成人对压力的日常情感反应
- 批准号:
2336167 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Standard Grant
RAPID: Affective Mechanisms of Adjustment in Diverse Emerging Adult Student Communities Before, During, and Beyond the COVID-19 Pandemic
RAPID:COVID-19 大流行之前、期间和之后不同新兴成人学生社区的情感调整机制
- 批准号:
2402691 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Standard Grant
Elucidation of Adult Newt Cells Regulating the ZRS enhancer during Limb Regeneration
阐明成体蝾螈细胞在肢体再生过程中调节 ZRS 增强子
- 批准号:
24K12150 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Migrant Youth and the Sociolegal Construction of Child and Adult Categories
流动青年与儿童和成人类别的社会法律建构
- 批准号:
2341428 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Standard Grant
Understanding how platelets mediate new neuron formation in the adult brain
了解血小板如何介导成人大脑中新神经元的形成
- 批准号:
DE240100561 - 财政年份:2024
- 资助金额:
$ 31.45万 - 项目类别:
Discovery Early Career Researcher Award
Laboratory testing and development of a new adult ankle splint
新型成人踝关节夹板的实验室测试和开发
- 批准号:
10065645 - 财政年份:2023
- 资助金额:
$ 31.45万 - 项目类别:
Collaborative R&D
Usefulness of a question prompt sheet for onco-fertility in adolescent and young adult patients under 25 years old.
问题提示表对于 25 岁以下青少年和年轻成年患者的肿瘤生育力的有用性。
- 批准号:
23K09542 - 财政年份:2023
- 资助金额:
$ 31.45万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Identification of new specific molecules associated with right ventricular dysfunction in adult patients with congenital heart disease
鉴定与成年先天性心脏病患者右心室功能障碍相关的新特异性分子
- 批准号:
23K07552 - 财政年份:2023
- 资助金额:
$ 31.45万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Issue identifications and model developments in transitional care for patients with adult congenital heart disease.
成人先天性心脏病患者过渡护理的问题识别和模型开发。
- 批准号:
23K07559 - 财政年份:2023
- 资助金额:
$ 31.45万 - 项目类别:
Grant-in-Aid for Scientific Research (C)