Driving Cutting Edge Clinical Trial Enrollment in Rural Populations: West Virginia's Mobile Clinical Trials Unit

推动农村人口的尖端临床试验注册：西弗吉尼亚州的移动临床试验单位

• 批准号: 10400301
• 负责人: Sally Lynn Hodder
• 金额: $ 35万
• 依托单位: WEST VIRGINIA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400301
• 关键词: Area; Automobile Driving; Chronic lung disease; Clinic; Clinical Trials; Clinical Trials Unit; Clinical assessments; Communities; Conduct Clinical Trials; Data; Enrollment; Ensure; Geography; Goals; Health; Heart Diseases; Impaired cognition; Individual; Laboratories; Malignant Neoplasms; Medical; Outcome; Participant; Patients; Persons; Population; Prevention trial; Privacy; Research; Rural; Rural Population; Sampling; Site; Slide; Stroke; Travel; United States; Visit; Weather; West Virginia; clinical trial enrollment; clinical trial participant; follow-up; improved; novel; participant enrollment; recruit; rural Americans; rural area; urban area

Clinical trial access to all populations is critically important to maintain scientific integrity, generalizability of results, and access to novel treatments only available through trials. Rural populations in the United States are underrepresented in clinical trials for multiple reasons, including geographic proximity of trial sites which have been demonstrated to be clustered around urban areas. Rural Americans are more likely to die from cancer, heart disease, stroke, and chronic lung diseases than persons living in urban areas, and the gap widened in recent years for cancer, heart disease, and chronic lung disease. Not surprisingly, many of the states with the worst health outcomes in 2019 contain large rural areas. Reasons for these disparities are likely multi-factorial, yet recent data in cancer suggest that availability of clinical trials may actually improve health outcomes. Mobile clinical trial units have been demonstrated to double enrollment in prevention trials among individuals with cognitive impairment with mobile unit participant enrollment exceeding enrollment in the main clinic. In the same study, other positive results included, increased community visibility of research and a community view that efforts were being made to accommodate them. The goal of this proposal is to vastly increase clinical trial access for rural West Virginia (WV) populations through procurement of a mobile laboratory with which to conduct clinical trial recruitment and follow-up visits throughout the state, including remote areas. The mobile facility contains a reception area where potential trial participants are welcomed and basic non-medical information is gathered. Two fully outfitted exam rooms provide privacy for medical assessment of clinical trial participants. A lab area (complete with refrigerator) for drawing and processing patient samples and a fully functional bathroom are also included in the mobile unit. A slide-out wall provides for the additional space facilitating adequate reception and exam room space and a retractable awning will provide for outdoor activity or waiting space, weather permitting. Importantly, outfitting the mobile unit with a diesel engine will ensure our ability to travel up and down the WV mountains to remote rural sites, thereby, bringing cutting- edge trials to the most out-of-the-way areas of our state.

向所有人群提供临床试验对于维护科学完整性至关重要， 结果的普遍性，以及只能通过试验才能获得的新疗法。乡村的 由于多种原因，美国人群在临床试验中的代表性不足， 包括已被证明聚集在周围的试验地点的地理邻近性 城市地区。美国农村地区更有可能死于癌症、心脏病、中风和 慢性肺病患者的患病率高于城市居民，且近年来差距不断扩大 癌症、心脏病和慢性肺病。毫不奇怪，许多州都拥有 2019 年健康状况最差的地区包括大片农村地区。造成这些差异的原因可能是 多因素的，但最近的癌症数据表明，临床试验的可用性实际上可能 改善健康结果。事实证明，移动临床试验单位可将入组人数翻倍 在有认知障碍的个体与移动设备参与者的预防试验中 注册人数超过了主要诊所的注册人数。在同一项研究中，其他积极结果 其中包括，提高社区对研究的知名度以及社区对正在开展的努力的看法 是为了容纳他们而设计的。该提案的目标是大幅增加临床试验的机会 通过购买移动实验室，为西弗吉尼亚州 (WV) 农村人口提供服务 在全州范围内进行临床试验招募和随访，包括远程 地区。移动设施包含一个接待区，欢迎潜在的试验参与者 并收集基本的非医疗信息。两间设备齐全的考试室提供隐私 用于临床试验参与者的医学评估。实验室区域（配有冰箱） 绘制和处理患者样本以及功能齐全的浴室也包含在其中 移动单元。滑出式墙提供了额外的空间，有助于充分接收和 检查室空间和可伸缩遮阳篷将提供户外活动或等候空间， 天气允许的话。重要的是，为移动装置配备柴油发动机将确保我们 能够在西弗吉尼亚州的山区上上下下到达偏远的农村地区，从而带来切割 在我们州最偏僻的地区进行边缘试验。