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。 对其余美国农村人口的观察表明，临床试验中的代表性一直偏低 几乎没有全面的数据资源来支持对健康和不良健康后果的相关性的研究。 关注贫困农村人口面临的健康问题的临床和转化(C/T)研究至关重要 解决和补救西弗吉尼亚人显著的健康差距。虽然在相当大的基础上 三个不同的核心(即伦理和法规知识、生物医学信息学)在1-5年间取得的成就 资源和临床试验研究股)，拟议的新核心，临床研究资源和 设施(CRRF)，是专门为解决招募农村参与者进入 用于临床试验，并支持对相关临床数据库的新分析。此外，CRRF还满足了这种需求 更高效、更及时地支持临床研究。CRRF核心的总体目标是 创建临床研究基础设施，将基础研究转化为临床实践，确保西弗吉尼亚州人 获得尖端临床试验并为与农村健康相关的研究问题提供答案 社区。这些总体目标将通过扩大研究伙伴关系来实现，以支持 继续开发和实施创新方法，以了解和改善健康状况 通过实现以下具体目标：1)创建临床试验卓越中心(CTCOE) 与农村社区和从业者建立联系，从而提供获得尖端试验的机会，以解决 影响西弗吉尼亚州人的健康差距，2)利用集成数据存储库(IDR2)，包括 200万人的临床数据，并通过阿巴拉契亚研究联盟建立合作伙伴关系，以促进 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健康研究的单位 和健康(NIOSH)。目标1的实现将带来进行1-4阶段试验的设施，而目标2将 不仅可以访问IDR2中200万WV患者的临床信息，还可以访问 肯塔基大学和辛辛那提大学。真正的创新是城市比较器的可用性， 通过连接到纽约市西奈山医疗中心的临床数据完成。最后，目标3 利用NIOSH的专业知识来检查能源提取方法对健康的影响。环境暴露 IDR2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.