Gulf South Minority/Underserved Clinical Trials Network (Gulf South M/U CTN)

虚拟研究护士计划(VRN)解决临床试验研究人员短缺问题 美国大多数成年癌症患者都是在社区肿瘤学实践中诊断和治疗的。然而&lt；5% 的患者参与临床试验，从而限制了科学进步的测试和实施 世界“设置。除了描述得很好的患者和医生对临床试验的障碍外，最近的 新冠肺炎给劳动人口带来的变化，包括“在家办公”的倡议，极大地促进了就业。 减少了训练有素的临床试验人员的数量。这些变化对社区的影响更严重 肿瘤学在城市和农村地区的实践，那里的研究基础设施有限，而且有能力 适应这些变化是困难的。墨西哥湾南部NCORP社区站点经历了严重的 应计项目减少的主要原因是研究人员短缺。我们建立了一个“虚拟研究” 护士“计划提供研究基础设施(法规、数据管理和研究护士)，以 通过虚拟手段建立社区网站。使用符合HIPAA标准的通信平台，我们帮助 城市和农村肿瘤学实践选择和开放感兴趣的临床试验，筛选和确定候选人 并方便患者的登记和随访。这种方法不同于传统的远程医疗，在 远程医疗主要为远程临床位置提供医生服务，而VRN计划 为寻求招募临床患者的社区肿瘤学家提供研究基础设施和功能 审判。我们的初步数据显示，位于中心的VRN有效地筛选了社区诊所， 确定临床试验的潜在候选者，并与社区肿瘤学家一起招募临床患者 审判。VRN还提供对患者的长期管理。此外，在与 Medidata解决方案我们将进一步简化VRN的实施，确保收集的数据 无缝转移到RAVE系统，从而最大限度地减少了手工转录数据的容易出错的过程。 我们相信VRN将大大促进社区肿瘤学实践的参与，并 患者参与临床试验，并帮助解决严重缺乏训练有素的临床试验人员和研究的问题 基础设施。我们建议：具体目标1a。协作完成VRN原型的开发 与Medidata Solutions合作，拥有一个可在NCORP站点使用的全功能平台。这将是一个证据 概念(POC)计划，旨在展示技术、培训和临床试验专业知识的使用 来支持这些诊所和病人。1B.将测试集成VRN计划的站点数量扩大到4个 地点(2个城市和2个农村)，以确定和比较在社区实施VRN计划的效果 城市和农村地区的肿瘤学实践。目标2：制定标准操作程序(SOP) 在其他临床中心实施VRN计划。

Virtual Research Nurse Program (VRN) Addressing Clinical Trials Research Personnel Shortage Most adult cancer patients in the US are diagnosed and treated in community oncology practices. However <5% of patients participate in clinical trials, thus limiting the testing and implementation of scientific advances in “real world” settings. In addition to the well described patient and physician related barriers to clinical trials, the recent changes to the workforce brought about by the COVID-19, including “work from home” initiatives have greatly decreased the number of trained clinical trials personnel. These changes more severely affect community oncology practices in both urban and rural locations where research infrastructure is limited and the ability to adapt to these changes is difficult. The Gulf South NCORP community sites have experienced a severe reduction in accruals due primarily to research personnel shortage. We established a “Virtual Research Nurse” program to provide research infrastructure (regulatory, data management and research nurse) to community sites through virtual means. Using a HIPAA-compliant communication platform we have helped urban and a rural oncology practices select and open clinical trials of interest, screen and identify candidate patients and facilitate their enrollment and follow-up. This approach is distinct from traditional telemedicine, in that telemedicine primarily provides physician services to a distant clinical location, while the VRN program provides the research infrastructure and functions to community oncologists seeking to enroll patients in clinical trials. Our preliminary data shows that a centrally located VRN efficiently screens the community clinics, identifies potential candidates for clinical trials and with the community oncologist enrolls patients on clinical trials. The VRN also provides long-term management of the patient. Furthermore, in collaboration with Medidata Solutions we will further streamline the implementation of VRN by ensuring that data collected is seamlessly transferred to the RAVE system, thus minimizing the error-prone process transcribing data by hand. We believe that the VRN will significantly facilitate the participation of community oncology practices and patients in clinical trials and help address the severe shortage of trained clinical trials personnel and research infrastructure. We propose to: Specific Aim 1a. Complete the development of the VRN prototype in collaboration with Medidata Solutions to have a fully functional platform that can be used in NCORP sites. This will be a Proof Of Concept (POC) program designed to demonstrate the use of technology, training, and clinical trial expertise to support these clinics and patients. 1b. Expand the number of sites to test the integrated VRN program to 4 sites (2 urban and 2 rural) to determine and compare the effect of implementing a VRN program at community oncology practices in urban and rural locations. Aim 2: Develop standard operating procedures (SOPs) for the implementation of the VRN program at other clinical centers.