Clinical Trials Logistics Core

儿童精神、情绪和行为障碍的患病率，以及儿童的患病率 肥胖，处于令人震惊的高水平，需要通过有效的预防来系统地解决 战略。儿童福祉研究中心的早期科学家正在进行密集的 部分由该中心的临床试验后勤核心研究机构(CTL)支持的预防试验 核心)。CTL核心寻求加强该中心预防措施的科学严谨性和透明度 干预临床试验，涉及对人类参与者进行干预的前瞻性分配 并评估与行为和健康相关的结果。CTL核心对于确保遵守 美国国立卫生研究院最新的临床试验政策。对中心的使命和目标至关重要的早期调查人员， 尚不具备纳入最新临床试验要求的经验和基础设施支持 他们的干预试验的概念化、实施和报告。对以下方面干预措施的评估 预防和减少与精神、情绪、行为和不健康生活方式相关的风险因素 童年需要在准备步骤、社区和学校方面得到实质性的支持和指导 参与度、试验报告需求、主要和次要结果的最新衡量，以及 重点评估干预措施的实施过程。CTL核心提供必要的 支持预防试验和相关研究的基础设施、仪器和技术专门知识 由早期调查人员进行，以在现实世界环境中严格实施干预措施。这个 CTL Core利用该中心当地的社区咨询委员会和经验丰富的工作人员来促进有效 社区和学校的参与。总体而言，CTL核心增强了独立和 在中心赞助的研究中通过确保：最先进的措施；良好的 指定和部署干预和测量方案；以及勤奋关注人类受试者的 协议和问题。CTL的核心目标包括：目标1：部署一支令人信服的团队以提供技术专长 和最先进的仪器设备，为该中心的早期调查人员进行高质量的预防 试验；目标2：为：(A)中心领导的早期研究项目提供支持和指导 关于其预防试验的准备、进行和报告的调查人员；(B)试点种子 项目；以及(C)通过过渡早期调查人员准备R01级研究项目；以及 目标3：为中心的早期调查人员、教职员工和工作人员举办技术培训讲习班，以及 进行涉及儿童的预防试验的其他大学教职员工，(1)社区参与和 参与；以及(2)临床试验的要求、遵从性和最佳实践。CTL核心提供 将调查人员提升到独立研究人员地位的关键支持。

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.