The IDeA State Consortium for a Clinical Research Resource Center: Increasing Clinical Trials in IDeA States through Communication of Opportunities, Effective Marketing, and WorkforceDevelopment

IDeA 州临床研究资源中心联盟：通过机会交流、有效营销和劳动力发展增加 IDeA 州的临床试验

• 批准号: 10715568
• 负责人: Sally Lynn Hodder
• 金额: $ 285.9万
• 依托单位: WEST VIRGINIA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10715568
• 关键词: Academy; Address; Adult; American; Area; Award; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Skills; Clinical Trials; Clinical and Translational Science Awards; Cohort Studies; Collaborations; Communication; Conduct Clinical Trials; Data; Databases; Decision Making; Development; Eligibility Determination; Enrollment; Ensure; Expenditure; Funding; Goals; Human Resources; Individual; Industry; Institution; Journals; Leadership; Long COVID; Marketing; Mentorship; Methods; Minority Groups; Minority Participation; Monitor; National Institute of General Medical Sciences; Observational Study; Participant; Patient Recruitments; Pharmacists; Phase; Principal Investigator; Program Development; Program Evaluation; Puerto Rico; Research; Research Personnel; Resources; Rural Population; Series; Services; Site; Structure; Time; Training; Translational Research; Underrepresented Minority; Underserved Population; United States; United States National Institutes of Health; West Virginia; clinical center; clinical trial participant; clinically relevant; eligible participant; experience; institutional capacity; interest; observational cohort study; online delivery; patient population; programs; repository; rural America; rural Americans; skills; success; web site

There are currently nearly 8,000 clinical trials and observational cohort studies funded by the National Institutes of Health in the United States, yet less than 10% of these studies are conducted in Institutional Development Award (IDeA) states that serve underrepresented minority and rural populations. Not surprisingly, only approximately 7% of expenditures for clinical trials and observational studies go to the 23 IDeA states and Puerto Rico. Barriers that limit expansion of clinical trial and cohort studies in IDeA states include lack of effective communication to trial sponsors of the expertise and capability that IDeA institutions possess to effectively conduct clinical studies, effective communication to IDeA investigators regarding clinical trials opportunities, and lack of clinical trial coordinators. The overall goal of this project is to increase numbers of clinical trials and observational cohort studies in IDeA states, thereby increasing trial availability and participation of minority and rural populations historically underrepresented in clinical trials. We will achieve this goal by establishing the IDeA State Consortium for Clinical Research Resource Center (ISCORE-RC) comprised of the Clinical Trials Service Center and the Clinical Research Coordinator (CRC) Development Program to address the identified barriers through accomplishment of the following specific aims. Aim 1 - Effectively communicate and market to clinical trial sponsors the expertise, quality, and capacity of IDeA state institutions to conduct clinical trials. We will accomplish this aim through several tactics to include leveraging the TriNetX platform that connects clinical trial sponsors with institutions serving relevant patient populations to identify sites with potentially eligible participants for specific clinical trials, creating a repository containing site-specific profiles showcasing strengths of individual IDeA state trial groups, establishing an ISCORE-RC website that provides a public resource to demonstrate benefits of partnering with IDeA organizations to increase clinical trial participant representation from underserved populations, and facilitating networking of sponsors with investigators. Aim 2 - Communicate to IDeA state investigators clinical trial opportunities. To accomplish this goal, we will develop site specific search criteria in clinicaltrials.gov that will allow the ISCORE-RC Clinical Trials Service Core to monitor relevant clinical trials of interest currently in the participant recruitment phase. Aim 3 - Train a cadre of skilled clinical research coordinators. Entry into this program will be open to experienced clinical personnel as well as to non-clinical individuals. Both part-time and full-time effort of trainees will be accommodated. The program will include an online didactic portion, journal club, and seminar series as well as a prominent experiential component to be conducted at participating sites. Upon completion of the core content, participants will receive a CRC basic training certificate and will be eligible for further training towards an advanced training certificate and membership in the ISCORE-RC CRC Academy, a networking and professional development platform that includes current research coordinators at participating sites as well as trainees.

目前有近 8,000 项由美国国立研究院资助的临床试验和观察队列研究 美国卫生部门，但这些研究中只有不到 10% 是在机构发展领域进行的 奖 (IDeA) 指出为代表性不足的少数族裔和农村人口提供服务。不足为奇，只是 大约 7% 的临床试验和观察性研究支出用于 23 个 IDeA 州和波多黎各 里科.限制 IDeA 州扩大临床试验和队列研究的障碍包括缺乏有效的 与试验申办者沟通 IDeA 机构拥有的专业知识和能力，以有效地 进行临床研究，就临床试验机会与 IDeA 研究人员进行有效沟通，以及 缺乏临床试验协调员。该项目的总体目标是增加临床试验的数量和 IDeA 州的观察性队列研究，从而提高了少数族裔和少数群体的试验可用性和参与度 历史上，农村人口在临床试验中的代表性不足。我们将通过建立IDeA来实现这一目标 国家临床研究资源中心联盟 (ISCORE-RC) 由临床试验服务组成 中心和临床研究协调员 (CRC) 发展计划旨在解决已发现的障碍 通过实现以下具体目标。目标 1 - 有效地沟通和营销 临床试验资助 IDeA 州立机构开展临床试验的专业知识、质量和能力 试验。我们将通过多种策略来实现这一目标，包括利用 TriNetX 平台 将临床试验申办者与服务相关患者群体的机构联系起来，以确定具有 潜在符合特定临床试验资格的参与者，创建包含特定站点配置文件的存储库 展示各个 IDeA 州试验小组的优势，建立 ISCORE-RC 网站，提供 公共资源展示与 IDeA 组织合作增加临床试验参与者的好处 服务不足人群的代表，并促进申办者与调查人员建立联系。目标 2 - 与 IDeA 州研究人员沟通临床试验机会。为了实现这一目标，我们将 在 ClinicalTrials.gov 中制定站点特定搜索标准，以允许 ISCORE-RC 临床试验服务核心 监测目前处于参与者招募阶段的相关临床试验。目标3——培养干部 熟练的临床研究协调员。参与该计划将向经验丰富的临床人员开放 以及非临床个体。实习生的兼职和全职工作都将得到满足。这 计划将包括在线教学部分、期刊俱乐部和研讨会系列以及著名的 体验部分将在参与地点进行。完成核心内容后，参与者 将获得 CRC 基础培训证书，并有资格接受进一步培训以获得高级培训 ISCORE-RC CRC 学院的证书和会员资格，这是一个网络和专业发展项目 该平台包括参与地点的当前研究协调员以及学员。