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.

所有人群的临床试验准入对于保持科学完整性至关重要， 结果的普遍性，以及只有通过试验才能获得的新治疗方法。农村 由于多种原因，美国的人群在临床试验中代表性不足， 包括试验中心的地理邻近性，这些试验中心已被证明聚集在 市区农村美国人更容易死于癌症，心脏病，中风， 慢性肺部疾病的发病率高于城市居民，而且这一差距差距近年来有所扩大， 癌症、心脏病和慢性肺病。毫不奇怪，许多国家的 2019年最糟糕的健康结果包括大部分农村地区。造成这些差异的原因可能是 多因素，但最近的癌症数据表明，临床试验的可用性实际上可能 改善健康成果。已证明移动的临床试验单位可使入组人数增加一倍 在有移动的单元参与者的认知障碍个体中进行的预防试验中 入组人数超过主诊所入组人数。在同一项研究中，其他积极的结果 包括，提高社区对研究的可见度，并使社区认为， 是为了适应他们。这项提案的目标是大大增加临床试验的准入 通过采购一个移动的实验室， 在全州范围内进行临床试验招募和随访，包括远程 地区移动的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。两个设备齐全的检查室提供隐私 用于临床试验参与者的医学评估。实验室区域（配有冰箱）， 绘制和处理病人样本和一个功能齐全的浴室也包括在 移动的单元。滑出式墙壁提供了额外的空间，便于充分接收， 检查室空间和可伸缩的遮阳篷将提供户外活动或等待空间， 天气允许的话。重要的是，为移动的装置配备柴油发动机将确保我们的 能够上下西弗吉尼亚山脉到偏远的农村地区，从而，带来切割- 把边缘试验带到我们州最偏远的地区