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

A recent analysis demonstrated that approximately 10% of NIH sponsored clinical trials were being conducted in Institutional Development Award (IDeA) states. Though reasons for underrepresentation in clinical trials are likely multifactorial, effective bidirectional communication between IDeA state institutions and clinical trial

sponsors is an important limitation. Sponsors of clinical trials, especially pharmaceutical industry sponsors, identify a number of key metrics by which a potential site is evaluated for clinical trial site selection. Important key clinical trial metrics include time required for contract negotiation, time required for IRB approval, time to site

activation, as well as metrics related to study recruitment and retention, and ability to recruit and retain participants from populations historically underrepresented in clinical trials. The IDeA State Consortium for Clinical Research Resource Center (ISCORE-RC) was launched in the fourth quarter of 2023 to increase clinical

trials in IDeA states through establishment of a service center to facilitate increased trial offerings and a clinical research coordinator program to address shortages of trained clinical trial personnel. There are eight ISCORE- RC charter member sites, and the lack of clinical trials infrastructure to capture relevant trial metrics at these

sites is a limitation to effective marketing to trial sponsors. This supplemental application seeks support for ISCORE-RC charter member sites to improve their infrastructure by either implementing a clinical trials management system or generating reports containing key clinical trial metrics from existing clinical trials

management systems. The ISCORE-RC will develop unique action plans for each of the charter member sites to enable collection and reporting of key trial metrics, thereby enhancing attractiveness for site selection by sponsors and CROs. This project is critically important to achieving the overarching goal of increasing clinical

trial offerings in IDeA states.