Montana Pediatric Clinical Trials Site

蒙大拿州儿科临床试验网站

• 批准号: 10064493
• 负责人: Paul Smith
• 金额: $ 39.88万
• 依托单位: UNIVERSITY OF MONTANA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10064493
• 关键词: Area; Biometry; Caring; Censuses; Center for Translational Science Activities; Child; Child Health; Childhood; Chronic; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical trial protocol document; Collaborations; Communities; Community Health; Complex; Computers; Consultations; Data; Databases; Development; Development Plans; Diabetes Mellitus; Disease; Ensure; Epidemiologist; Family Practice; Federally Qualified Health Center; Funding; Future; Geography; Goals; Group Practice; Growth; Health; Health Care Research; Health Personnel; Health Sciences; Healthcare; Infrastructure; Inpatients; Institution; Investigation; Laboratories; Leadership; Malignant Neoplasms; Manuscripts; Medical; Medicine; Mentorship; Monitor; Montana; Multi-Institutional Clinical Trial; Multicenter Studies; Native Americans; Nurses; Nursing Research; Obesity; Outpatients; Participant; Pathway interactions; Patient Recruitments; Pharmacy facility; Phase; Population; Positioning Attribute; Poverty; Principal Investigator; Process; Public Health Schools; Quality of life; Research; Research Design; Research Personnel; Residencies; Resources; Risk; Role; Rural; Rural Community; Rural Population; Scientist; Secure; Services; Site; Structure; Teacher Professional Development; Telemedicine; Time; Travel; United States National Institutes of Health; Universities; Writing; care providers; care systems; clinical research site; cost; design; experience; health care disparity; improved; innovation; leadership development; member; neurodevelopment; operation; outreach; pediatrician; programs; protocol development; recruit; research and development; rural area; rural underserved; senior faculty; skill acquisition; success; telehealth; tertiary care; tribal community

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.

项目概要 在 ECHO IDeA 州儿科临床试验网络 (ECHO ISPCTN) 的头四年里， 蒙大拿州儿科临床试验中心 (MPCTS) 已成功建设必要的基础设施， 团队和合作伙伴有效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、参与者专用考试和咨询室、数据库和 蒙大拿大学多个中心的计算机设施和临床研究专业知识。这 研究小组由一名儿科临床医生/科学家（作为首席研究员）、两名研究护士、一名 流行病学家和最近增加的第二位儿科医生。每个团队成员都通过以下方式获得了经验 多个专业发展机会，其中包括 ECHO ISPCTN 数据协调和 运营中心提供教学演示、手稿写作团队成员资格和领导力、临床 试验方案开发的领导地位，最重要的是参与带来的宝贵增长 在三项 ECHO ISPCTN 临床研究中。该团队现在处于有利位置，可以从强大的临床研究中进一步获益 研究技能发展计划由新任高级教师发展领导者设计，他拥有广泛的研究技能 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正在进行的 ECHO ISPCTN 试验以及临床试验正在开发中。促进持续和成功的儿科临床 参与试验，我们已与该州主要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，以及门诊儿科诊所 整个蒙大拿州西部的团体和护理提供者，包括家庭医学住院医师和 合作健康中心，联邦合格的健康中心。我们还得到了新人的支持 成立了创新型农村外展组织 Ahana，这是一个针对农村下班后护理的远程医疗合作组织 社区。我们已建立并积极参与两个 IDeA 计划支持的临床和 蒙大拿州的转化研究中心已经并将继续作为宝贵的资源 专业发展、研究设计和生物统计学以及社区和利益相关者的参与， 当我们将 ECHO ISPCTN 活动扩展到该州更多农村地区时，最后一点至关重要。回声 ISPCTN 提供了一条将历史上从未这样做过的站点纳入临床试验研究的途径。 展望未来，我们的总体目标是以 ECHO ISPCTN 和 MPCTS 的成功为基础， 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 蒙大拿州地区。更具包容性和普遍性的儿科临床试验将提高临床试验的质量 ECHO ISPCTN 的临床试验研究和儿童健康。