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

目前有近8000项临床试验和观察性队列研究由美国国家研究院资助 然而，这些研究中只有不到10%是在机构发展方面进行的 奖励(IDEA)为代表不足的少数民族和农村人口服务的州。毫不奇怪，只是 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。在理想状态下限制临床试验和队列研究扩展的障碍包括缺乏有效的 向试验发起人传达IDEA机构拥有的专业知识和能力，以有效地 进行临床研究，与IDEA研究人员就临床试验机会进行有效沟通，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和 IDEA状态下的观察性队列研究，从而增加试验的可用性和少数人和 农村人口在临床试验中的比例历来偏低。我们将通过确立这一理念来实现这一目标 由临床试验服务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)发展计划，以解决已确定的障碍 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IDEA州立机构进行临床试验的专业知识、质量和能力 审判。我们将通过几种策略来实现这一目标，包括利用TriNetX平台 将临床试验赞助商与为相关患者群体提供服务的机构联系起来，以确定具有 可能有资格参加特定临床试验的参与者，创建包含特定站点配置文件的存储库 展示个别Idea州试验小组的优势，建立一个iScore-RC网站，提供 展示与IDEA组织合作增加临床试验参与者的好处的公共资源 来自服务不足人群的代表，并促进赞助商与调查人员建立网络联系。目标2- 与IDEA州研究人员交流临床试验机会。为了实现这一目标，我们将 在Clinicaltrials.gov中开发特定于站点的搜索标准，以允许iScore-RC临床试验服务核心 监测目前正处于参与者招募阶段的相关临床试验。目标3--培训干部 熟练的临床研究协调员。有经验的临床人员可以参加这个项目。 也适用于非临床个体。学员的兼职和全职工作都将得到考虑。这个 该计划将包括在线教学部分，杂志俱乐部，研讨会系列以及著名的 体验部分将在参与地点进行。在核心内容完成后，参与者 将获得CRC基本培训证书，并将有资格接受进一步培训，以获得高级培训 IScore-RC CRC Academy的证书和成员资格，网络和专业发展 该平台包括参与地点的现任研究协调员和受训人员。

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.