Clinical Research Resources and Facilities

在过去的15年里，阿巴拉契亚的死亡率一直在上升，而死亡率却在下降 在美国其余地区观察到，农村人口在临床试验中的代表性一直不足， 很少有全面的数据资源支持对健康和不良健康结果的相关性的研究。 临床和翻译（C/T）研究的重点是农村贫困人口面临的健康问题是至关重要的 解决和补救西弗吉尼亚州的重大健康差距。在建立在相当大的 在三个不同的核心（即伦理与监管知识，生物医学信息学）的1-5年的成就 临床研究资源及临床试验研究组）、拟议的新核心临床研究资源及 专门设计了CRRF，以解决招募农村参与者的局限性， 临床试验，并支持相关临床数据库的新分析。此外，CRRF还满足了 更有效和及时的流程来支持临床研究。CRRF核心的总体目标是 建立临床研究基础设施，将基础研究转化为临床实践， 获得尖端的临床试验，并回答与农村人口健康有关的研究问题， 社区.这些总体目标将通过扩大研究伙伴关系来实现， 继续制定和实施创新方法，以了解和改善 WV通过实现以下具体目标：1）创建卓越临床试验中心（CTCOE） 与农村社区和从业人员建立联系，从而提供获得尖端试验的机会， 影响西弗吉尼亚州的健康差异，2）利用综合数据库（IDR 2）， 200万人的临床数据，并通过阿巴拉契亚研究联盟建立伙伴关系， 结果研究、预测建模和地理空间分析，以及3）建立环境暴露 与国家职业安全研究所合作促进环境卫生研究的单位 健康（NIOSH）。目标1的实现将使设施能够进行1-4期试验，而目标2将 不仅可以访问IDR 2中200万WV患者的临床信息，还可以访问 肯塔基州和辛辛那提的大学。真正的创新是提供了一个城市比较器， 通过连接到纽约市西奈山医学中心的临床数据来完成。第三，目标 利用NIOSH的专业知识来研究能源提取方法对健康的影响。环境暴露 IDR 2数据的地理空间编码的可用性将加强研究。

Mortality in Appalachia has consistently risen over the past fifteen years, in contrast to decreasing mortality rates observed for the remainder of the U.S. Rural populations are consistently underrepresented in clinical trials, and few comprehensive data resources exist to support studies of health and correlates of adverse health outcomes. Clinical and Translation (C/T) research focused on the health issues confronting poor rural populations is critical to addressing and remediating WV's significant health disparities. While building on the considerable achievements in Years 1-5 of three distinct cores (i.e. Ethics & Regulatory Knowledge, Biomedical Informatics Resources, and Clinical Trials Research Unit), the proposed new core, Clinical Research Resources and Facilities (CRRF), has been specifically designed to address the limitations of recruiting rural participants into clinical trials and to support new analyses of relevant clinical databases. In addition, CRRF addresses the need for more efficient and timely processes for supporting clinical research. The overall goals of the CRRF core are to create clinical research infrastructures to translate basic research to clinical practice, assuring West Virginians access to cutting edge clinical trials and providing answers to research questions relevant to the health of rural communities. These overall goals will be accomplished by expanding research partnerships to support continued development and implementation of innovative approaches to understand and improve the health of WV through realization of the following specific aims: 1) create a Clinical Trials Center of Excellence (CTCOE) with connection to rural communities and practitioners, thereby providing access to cutting-edge trials addressing health disparities affecting West Virginians, 2) leverage the Integrated Data Repository (IDR2), containing clinical data on 2 million persons, and partnership through the Appalachian Research Consortium to facilitate outcomes research, predictive modeling, and geospatial analysis, and 3) establish the Environmental Exposures Unit to stimulate environmental health research in collaboration with the National Institute for Occupational Safety and Health (NIOSH). Achievement of Aim 1 will result in facilities to conduct Phase 1-4 trials while Aim 2 will provide access to clinical information from not only the 2 million WV patients in IDR2, but to clinical data from the Universities of Kentucky and Cincinnati. Truly innovative is the availability of an urban comparator, accomplished by connection to clinical data from Mount Sinai Medical Center in New York City. Finally, Aim 3 leverages NIOSH expertise to examine the health impact of energy extraction methods. Environmental exposure studies will be enhanced by the availability of geospatial coding of IDR2 data.