Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trials Network

项目总结/摘要 每年在阿肯色州的拉斐特县，每1,000个婴儿中就有16个在一岁生日前死亡; 死亡率高于许多第二世界国家。36%的阿肯色州居民 在农村地区，几乎三分之一的儿童生活在贫困中，所有县的医疗服务都不足。2阿肯色州 是一个IDEA州，并加入了类似的农村州的这些差异。生活在农村和农村地区的婴儿和儿童 医疗服务不足的州比那些生活在城市州的人更不可能参加并受益 3 -5为了解决儿科研究中的这种差异， 环境对儿童健康结果的影响（ECHO）倡议将建立IDEA国家 儿科临床试验网络（ISPCTN），以增加儿童临床试验的代表性和可及性 在服务水平低下的州，国家卫生研究院的资金不成比例地低。最多15个位于IDEA州的临床研究中心将 由一个数据协调和运营中心（DCOC）提供资金和支持。因此， 阿肯色州医学科学（UAMS）建议创建DCOC。作为一个学术医疗中心， 强大的临床研究组合和在农村和服务不足地区进行研究的经验， UAMS的拟议团队很适合担任DCOC。关键人员在四个ECHO中工作 并准备帮助ISPCTN网站做同样的事情。DCOC将与 ISPCTN临床中心将在IDEA州建立儿科临床研究的能力并增加其可及性 以增加试验结果的普遍性。为了建立DCOC，UAMS将： 具体目标1：建立协调中心基础设施，以支持 美国儿科临床试验网络。拟议的DCOC将创造一个具有成本效益的 运营和数据协调基础设施，以支持ISPCTN临床试验。 具体目标2：执行DCOC的业务任务和科学职责， 在合作协议中。DCOC将支持运营，物流，数据 ISPCTN的管理和生物统计需求。 具体目标3：制定和实施相关的专业发展方案， 在IDEA州的儿科临床试验团队。DCOC将利用现有的 提供专业发展和指导的基础设施。 DCOC的目标是支持临床研究的开发和实施， ISPCTN。UAMS团队将与ISPCTN研究中心的临床研究者合作， 科学家、项目官员和其他NIGMS和NICHD工作人员选择或设计、实施和监督 针对ECHO优先领域和生活在IDEA州的儿童的健康需求的临床试验。

PROJECT SUMMARY/ABSTRACT Each year in Lafayette County, Arkansas, 16 of every 1,000 infants die before their first birthday;1 this infant mortality rate is greater than that of many second-world countries. Thirty-six percent of Arkansas residents live in rural areas, almost one in three children lives in poverty, and all counties are medically underserved.2 Arkansas is an IDeA state and is joined in these disparities by similarly rural states. Infants and children living in rural and medically underserved IDeA states are less likely than those living in urban states to be enrolled in and benefit from clinical research, especially clinical trials.3-5 To address this disparity in pediatric research, the Environmental Influences on Children Health Outcomes (ECHO) initiatives will establish the IDeA States Pediatric Clinical Trials Network (ISPCTN) to increase representation of and access to clinical trials by children in underserved states with disproportionately low NIH funding. Up to 15 clinical sites located in IDeA states will be funded and supported by one Data Coordinating and Operations Center (DCOC). As such, the University of Arkansas for Medical Sciences (UAMS) proposes to create the DCOC. Being an academic medical center with a robust clinical research portfolio and experience with conducting research in rural and underserved areas, the proposed team at UAMS is well positioned to serve as the DCOC. The key personnel work across the four ECHO priority areas and are prepared to help ISPCTN sites do the same. The DCOC will work collaboratively with ISPCTN clinical centers to build capability for and increase access to pediatric clinical research in IDeA states to increase generalizability of trial results. To establish the DCOC, UAMS will:  Specific Aim 1: Establish a coordinating center infrastructure to support trials conducted by the IDeA States Pediatric Clinical Trials Network. The proposed DCOC will create a cost-effective operations and data-coordinating infrastructure to support ISPCTN clinical trials.  Specific Aim 2: Execute the operational tasks and scientific responsibilities of the DCOC as required within the collaborative agreement. The DCOC will support the operations, logistics, data management, and biostatistics needs of the ISPCTN.  Specific Aim 3: Develop and implement relevant professional development programs to establish highly competent pediatric clinical trial teams in IDeA states. The DCOC will leverage existing infrastructure to provide professional development and mentoring. The objective of the DCOC is to support the development and implementation of clinical research within the ISPCTN. The UAMS team will work collaboratively with clinical investigators at the ISPCTN sites, Project Scientists, Program Officials, and other NIGMS and NICHD staff to select or design, implement and oversee clinical trials addressing the ECHO priority areas and the health needs of children living in IDeA states.