Clinical Research Resources and Facilities Core

美国农村人更有可能死于癌症、心脏病、中风、慢性肺部疾病，甚至 SARS-CoV-2感染比生活在城市地区的人更多，而农村人口一直是 在临床试验中代表性不足。临床研究集中在不同农村面临的健康问题 人口对解决和补救西弗吉尼亚州(西弗吉尼亚州)严重的健康差距至关重要。这个 临床研究资源和设施(CRRF)核心的总体目标是克服临床研究的障碍 农村居民在支持下一代临床医学发展的同时面临的研究参与 并确保最高质量的研究进行。建立在可观的CRRF核心之上 6-10年取得的成就，包括实施临床试验卓越中心(COE)， 我们将通过实现三个具体目标来完成总目标。具体目标1是开发 全面的基础设施和跨西弗吉尼亚州的协作，促进临床研究的参与 多样化的农村人口。我们将使用几种策略来实现这一目标。两个新的临床试验合作伙伴， 伯克利医疗中心/西弗吉尼亚大学东部校区，位于西弗吉尼亚州东部狭长地带，以及退伍军人事务部 (VA)在亨廷顿的设施，扩大WVCTSI临床试验的地理足迹。现有临床试验 WVCTSI现有合作伙伴马歇尔大学和查尔斯顿地区医疗中心的中心将增加 通过建立WVCTSI临床试验委员会，在COE保护伞下紧密结合。 重要的是，我们新的国家卫生研究院资助的移动临床试验单位，39英尺长的Winnebago 定制包括两个检查室和实验室空间，将为WVCTSI调查人员提供 在西弗吉尼亚州农村最偏远的角落招募研究参与者。最后，我们将实施和推广远程医疗 作为一个临床研究平台，接触到全州的潜在参与者。特定目标2将建立强大的 通过为下一代临床试验人员提供以下技能和资格来建立临床研究团队 有效地领导研究团队。首席调查员(PI)学院，在目前的资金中建立 周期，将为讨论临床试验问题和指导早期研究人员提供一个论坛。至 解决西弗吉尼亚州学习协调员严重短缺的问题，我们将开发和实施在线证书 临床试验协调方案，与西弗吉尼亚大学护理学院合作。在具体目标3中，我们 将在所有WVCTSI临床试验站点开发和实施一套标准化的性能指标，以 推动临床试验效率和质量。由于现场表现卓越对参与者的安全至关重要 和任何临床试验的成功，我们将实施一系列指标，以便于及时识别和 解决可能影响参与者安全、研究效率和/或研究影响的潜在问题。这个 指标将由WVCTSI临床试验委员会审查并达成一致。

Rural Americans are more likely to die from cancer, heart disease, stroke, chronic lung diseases, and even SARS-CoV-2 infection than persons living in urban areas, yet rural populations are consistently underrepresented in clinical trials. Clinical research focused on the health issues confronting diverse rural populations is critical to addressing and remediating West Virginia’s (WV) significant health disparities. The overall goal of the Clinical Research Resources and Facilities (CRRF) Core is to overcome obstacles to clinical study participation faced by rural residents while supporting the development of the next generation of clinical trialists and ensuring the highest quality of study conduct. Building on the considerable CRRF Core achievements in Years 6-10 that included implementation of the Clinical Trials Center of Excellence (COE), we will accomplish the overall goal by achieving three specific aims. Specific Aim 1 is to develop comprehensive infrastructure and collaborations across WV that facilitate clinical study participation among diverse rural populations. We will accomplish this aim using several strategies. Two new clinical trials partners, Berkeley Medical Center/WVU Eastern Campus, located in WV’s eastern panhandle, and the Veterans Affairs (VA) facility in Huntington, expand the geographic footprint of WVCTSI clinical trials. Existing clinical trials centers at established WVCTSI partners, Marshall University and Charleston Area Medical Center, will be more closely aligned under the COE umbrella through the establishment of the WVCTSI Clinical Trials Council. Importantly, our new National Institutes of Health-funded mobile clinical trials unit, a 39-foot Winnebago customized to include two exam rooms and laboratory space, will provide WVCTSI investigators the ability to enroll study participants in the farthest corners of rural WV. Finally, we will implement and promote telehealth as a clinical research platform to reach potential participants across the state. Specific Aim 2 will build strong clinical research teams by providing the next generation of clinical trialists with the skills and qualifications to effectively lead research teams. The Principal Investigators’ (PI) Academy, established in the current funding cycle, will provide a forum for discussion of clinical trial issues and mentoring of early-stage investigators. To address a critical shortage of study coordinators in WV, we will develop and implement an online certificate program in clinical trial coordination, in collaboration with the WVU School of Nursing. In Specific Aim 3 we will develop and implement a standardized set of performance metrics across all WVCTSI clinical trial sites to drive clinical trial efficiency and quality. As site performance excellence is critical to the safety of participants and the success of any clinical trial, we will implement a menu of metrics to facilitate timely identification and resolution of potential problems that may affect participant safety, study efficiency, and/or study impact. The metrics will be reviewed and agreed upon by the WVCTSI Clinical Trials Council.