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项临床试验和观察性队列研究由美国国立研究院资助 在美国的健康，但不到10%的这些研究是在机构发展进行的 奖（IDEA）规定，服务于代表性不足的少数民族和农村人口。毫不奇怪，只有 大约7%的临床试验和观察性研究支出用于23个州和波多黎各 瑞可限制IDEA州临床试验和队列研究扩展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， 开展临床研究，就临床试验机会与IDEA研究者进行有效沟通，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， IDEA州的观察性队列研究，从而增加试验的可用性和少数族裔和少数族裔的参与 农村人口在临床试验中的代表性历来不足。我们将通过建立IDEA来实现这一目标 由临床试验服务部门组成的国家临床研究资源中心联盟（ISCORE-RC） 中心和临床研究协调员（CRC）开发计划，以解决已识别的障碍 通过实现以下具体目标。目标1 -有效沟通和营销 临床试验赞助商的专业知识，质量和能力的IDEA国家机构进行临床 审判我们将通过多种策略实现这一目标，包括利用TriNetX平台， 将临床试验申办者与服务于相关患者人群的机构联系起来，以确定具有 特定临床试验的潜在合格参与者，创建包含特定研究中心配置文件的存储库 展示各个IDEA州试验组的优势，建立一个ISCORE-RC网站， 展示与IDEA组织合作以增加临床试验参与者的益处的公共资源 代表性不足的人口，并促进赞助商与调查人员的网络。目标2 - 与IDEA州研究者沟通临床试验机会。为了实现这一目标，我们将 在clinicaltrials.gov中制定研究中心特定的搜索标准，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。进入这个程序将开放给有经验的临床人员 以及非临床个体。学员的兼职和全职工作都将得到照顾。的 该计划将包括一个在线教学部分，期刊俱乐部，和研讨会系列，以及一个突出的 将在参与地点进行体验部分。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，以进行高级培训 证书和ISCORE-RC CRC学院的成员资格，这是一个网络和专业发展 该平台包括参与研究中心的现有研究协调员以及受训人员。