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次临床试验和由国立研究所资助的观察队列研究 在美国的健康状况中，不到10％的研究是在机构发展中进行的 奖项（想法）指出，为代表性不足的少数群体和农村人口提供服务。毫不奇怪，只有 大约7％的临床试验支出和观察性研究的支出用于23个思想状态和波多黎各 Rico。限制临床试验和队列研究的障碍，包括缺乏有效的障碍 与审判发起人的沟通，以有效的思想机构所拥有的专业知识和能力 进行临床研究，与Idea研究者有关临床试验机会的有效沟通，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 在思想状态中的观察队列研究，从而增加了少数族裔的审判可用性和参与 在临床试验中，农村人口历史上的人数不足。我们将通过建立这个想法来实现这一目标 临床研究资源中心（ISCORE-RC）的国家财团由临床试验服务组成 中心和临床研究协调员（CRC）开发计划，以解决已确定的障碍 通过实现以下特定目标。目标1-有效地交流和市场 临床试验赞助了思想国家机构进行临床的专业知识，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 将临床试验发起人与服务相关患者人群的机构联系起来，以识别与 特定临床试验的潜在符合条件的参与者，创建了一个包含特定地点概况的存储库 展示个人思想州试验小组的优势，建立一个ISCORE-RC网站，该网站提供 公共资源以证明与想法组织合作以增加临床试验参与者的好处 服务不足的人群的代表，并促进了赞助商与研究人员的网络。目标2- 与想法的国家调查人员沟通临床试验机会。为了实现这一目标，我们将 在ClinicalTrials.gov中开发特定网站的搜索标准，该标准将允许ISCore-RC临床试验核心 监视参与者招聘阶段目前的相关临床试验。瞄准3-训练干部 熟练的临床研究协调员。进入该计划将向经验丰富的临床人员开放 以及非临床个体。学员的兼职和全职工作都将得到适应。这 节目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 在参与地点进行的经验成分。核心内容完成后，参与者 将获得CRC基本培训证书，并有资格接受进一步的培训 ISCore-RC CRC学院的证书和会员资格，网络和专业发展 平台包括当前的参与站点和学员的研究协调员。