Montana Pediatric Clinical Trials Site

项目总结 在ECHO IDEA国家儿科临床试验网络(ECHO ISPCTN)的头四年里， 蒙大拿州儿科临床试验网站(MPCTS)已经成功地建立了必要的基础设施， 团队和合作伙伴有效地参与多中心临床试验。新组建的基础设施 包括临床和研究办公室，为参与者提供专门的检查和会诊室，数据库和 通过蒙大拿大学的几个中心的计算机设施和临床研究专业知识。这个 研究团队由一名儿科临床医生/科学家担任首席研究员，两名研究护士，以及 流行病学家和最近增加的第二名儿科医生。每个团队成员都通过 多个专业发展机会，包括ECHO ISPCTN数据协调和 运营中心-提供讲授演示、手稿写作团队成员和领导力、临床 试验方案开发的领导力，最重要的是参与带来的无价增长 在三项ECHO ISPCTN临床研究中。该团队现在已经做好了充分的准备，可以从强大的临床 由新的高级教师发展主管设计的研究技能发展计划，他拥有广泛的 在临床试验和指导方面的专业知识。我们已准备好参与下一阶段的持续回应 ISPCTN试验以及正在开发的临床试验。以促进儿科临床的持续和成功 通过参与试验，我们已经与该州主要的儿科住院机构建立了关系， 包括他们的医疗保健提供者和研究机构，以及门诊儿科实践 蒙大拿州西部的团体和护理提供者，包括家庭执业医学住院医师和 伙伴关系健康中心，一家联邦合格的健康中心。我们还获得了一个新的 成立了创新型农村外展组织Ahana，这是一个为农村地区提供下班后护理的远程医疗协作体 社区。我们已经建立并积极参与了两个IDEA计划-支持的临床和 蒙大拿州的翻译研究中心已经并将继续作为有价值的资源 专业发展、研究设计和生物统计，以及社区和利益相关者的参与， 随着我们将ECHO ISPCTN活动扩展到该州更多的农村地区，最后一项至关重要。回声 ISPCTN为在临床试验研究中纳入历史上没有这样做的站点提供了一条途径。 展望未来，我们的总体目标是在ECHO ISPCTN和MPCTS的成功和 利用现有基础设施将ECHO ISPCTN临床试验的覆盖范围扩大到农村和服务不足的地区 蒙大拿州的一些地区。更具包容性和普适性的儿科临床试验将提高 跨越ECHO ISPCTN的临床试验研究和儿童健康。

PROJECT SUMMARY During the first four years of the ECHO IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN), the Montana Pediatric Clinical Trials Site (MPCTS) has been successful in building the necessary infrastructure, team, and partnerships to participate effectively in multi-center clinical trials. The newly formed infrastructure includes clinical and research offices, dedicated exam and consultation rooms for participants, database and computer facilities and clinical research expertise from several centers through the University of Montana. The research team is comprised of a pediatric clinician/scientist as principal investigator, two research nurses, an epidemiologist and a recently added second pediatrician. Each team member has gained experience through multiple professional development opportunities, which have included ECHO ISPCTN Data Coordinating and Operations Center-offered didactic presentations, manuscript writing team membership and leadership, clinical trial protocol development leadership, and most importantly the invaluable growth that occurs with participation in three ECHO ISPCTN clinical studies. The team is now well positioned to gain further from a robust clinical research skills development plan designed by a new Senior Faculty Development Leader, who has extensive expertise in both clinical trials and mentorship. We are ready to participate in the next phase of ongoing ECHO ISPCTN trials as well as clinical trials in development. To facilitate continued and successful pediatric clinical trial participation, we have established relationships with the major pediatric inpatient facilities in the state, including their healthcare providers and research institutions, as well as with outpatient pediatric practice groups and care providers throughout western Montana, including the Family Practice Medicine Residency and Partnership Health Center, a Federally Qualified Health Center. We have also gained support from a newly formed innovative rural outreach organization, Ahana, a telemedicine collaborative for afterhours care in rural communities. Our established and active engagement with two IDeA program-supported Clinical and Translational Research Centers in Montana has and will continue to serve as valuable resources in professional development, research design and biostatistics, and community and stakeholder engagement, the last of which is critical as we extend our ECHO ISPCTN activities into more rural areas of the state. The ECHO ISPCTN has provided a pathway for including sites in clinical trial research that have not historically done so. As we look toward the future, the overall goal is to build on the ECHO ISPCTN’s and MPCTS’s successes and leverage existing infrastructure to expand the reach of ECHO ISPCTN clinical trials into rural and underserved areas in Montana. More inclusive and generalizable pediatric clinical trials will improve both the quality of clinical trial research and the health of children across the ECHO ISPCTN.