Clinical Research Resources and Facilities Core

美国农村人更容易死于癌症、心脏病、中风、慢性肺病， SARS-CoV-2感染率高于城市居民，但农村居民 在临床试验中代表性不足。临床研究集中在农村面临的各种健康问题， 人口是至关重要的，以解决和补救西弗吉尼亚州（西弗吉尼亚州）的重大健康差距。的 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， 农村居民面临的研究参与，同时支持下一代临床 确保最高的研究质量。基于可观的CRRF核心 在6-10年级取得的成就，包括实施卓越的临床试验中心（COE）， 我们将通过三个具体目标来实现总目标。具体目标1：发展 西弗吉尼亚州全面的基础设施和协作，促进临床研究参与， 不同的农村人口。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/西弗吉尼亚大学东校区，位于西弗吉尼亚州的东部狭长地带，和退伍军人事务部 (VA)位于亨廷顿的WVCTSI实验室，扩大了WVCTSI临床试验的地理覆盖范围。现有临床试验 在建立WVCTSI合作伙伴，马歇尔大学和查尔斯顿地区医疗中心的中心，将更多 通过建立WVCTSI临床试验理事会，在COE框架下紧密协调。 重要的是，我们新的国家卫生研究院资助的移动的临床试验单位，一个39英尺的温尼贝戈 定制，包括两个检查室和实验室空间，将提供WVCTSI研究人员的能力， 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保健 作为一个临床研究平台，以达到整个国家的潜在参与者。第2章将强势崛起 临床研究团队，为下一代临床试验人员提供技能和资格， 有效领导科研团队。主要研究者（PI）学院，在目前的资金中成立 周期，将提供一个讨论临床试验问题和指导早期研究者的论坛。到 为了解决西弗吉尼亚州学习协调员的严重短缺问题，我们将开发和实施在线证书 临床试验协调计划，与护理西弗吉尼亚大学学院合作。具体目标3 将在所有WVCTSI临床试验中心制定并实施一套标准化的性能指标， 提高临床试验的效率和质量。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，以促进及时识别和 解决可能影响受试者安全、研究效率和/或研究影响的潜在问题。的 WVCTSI临床试验理事会将对指标进行审查并达成一致。

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.