Clinical Trials Logistics Core

点击翻译按钮获取中文摘要

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.