Montana Pediatric Clinical Trials Site

蒙大拿州儿科临床试验网站

• 批准号: 10472686
• 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/10472686
• 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; Persons; 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; community engagement; cost; design; experience; health care disparity; improved; innovation; leadership development; member; neurodevelopment; operation; outreach; pediatrician; programs; protocol development; recruit; research and development; rural area; senior faculty; skill acquisition; success; telehealth; tertiary care; tribal community; underserved area; underserved 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.

项目摘要 在回声构想的前四年中，儿科临床试验网络（Echo ISPCTN）， 蒙大拿州小儿临床试验现场（MPCTS）已成功建立必要的基础设施， 团队和合作伙伴关系有效地参与了多中心临床试验。新形成的基础设施 包括临床和研究办公室，专门的考试和参与者的咨询室，数据库和 来自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 研究团队完成了一名儿科临床/科学家，担任首席研究员，两名研究护士，一个 流行病学家和最近增加的第二个儿科医生。每个团队成员都通过 多种专业发展机会，其中包括Echo ISPCTN数据协调和 运营中心提供的教学演示，手稿写作团队成员和领导力，临床 试验协议开发领导层，最重要的是参与随着参与的宝贵增长 在三个Echo ISPCTN临床研究中。该团队现在处于良好的位置，可以从强大的临床上获得进一步的收益 由新的高级教师发展领导者设计的研究技能发展计划，他拥有广泛的 临床试验和心态方面的专业知识。我们准备参加下一阶段的回声 ISPCTN试验以及开发的临床试验。促进持续和成功的小儿临床 试用参与，我们已经与该州主要的儿科住院设施建立了关系， 包括其医疗保健提供者和研究机构，以及门诊儿科实践 整个蒙大拿州西部的团体和护理提供者，包括家庭实践医学居住权和 合伙人健康中心，一个有资格的健康中心。我们也得到了新的支持 成立了创新的农村外展组织Ahana，Ahana，远程医疗合作，用于农村的后代护理 社区。我们建立并积极参与了两个想法计划支持的临床和 蒙大拿州的转化研究中心已经并且将继续作为宝贵资源 专业发展，研究设计和生物统计学以及社区和利益相关者参与， 当我们将回声ISPCTN活动扩展到国家更农村地区时，其中的最后一个至关重要。回声 ISPCTN提供了一条途径，可以将其包括在临床试验研究中，而历史上没有这样做。 当我们展望未来时，总体目标是建立在Echo ISPCTN和MPCT的成功之上，并且 利用现有的基础设施将Echo ISPCTN临床试验的影响范围扩展到农村和服务不足 蒙大拿州的地区。更具包容性和可概括的儿科临床试验将提高 临床试验研究和整个Echo ISPCTN的儿童的健康。