U24GM150446

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.

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.

West Virginia University Research Corporation

THE NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) SUPPORTS BASIC RESEARCH THAT INCREASES OUR UNDERSTANDING OF BIOLOGICAL PROCESSES AND LAYS THE FOUNDATION FOR ADVANCES IN DISEASE DIAGNOSIS, TREATMENT, AND PREVENTION. NIGMS ALSO SUPPORTS RESEARCH IN SPECIFIC CLINICAL AREAS THAT AFFECT MULTIPLE ORGAN SYSTEMS: ANESTHESIOLOGY AND PERI-OPERATIVE PAIN, CLINICAL PHARMACOLOGY ?COMMON TO MULTIPLE DRUGS AND TREATMENTS, AND INJURY, CRITICAL ILLNESS, SEPSIS, AND WOUND HEALING.? NIGMS-FUNDED SCIENTISTS INVESTIGATE HOW LIVING SYSTEMS WORK AT A RANGE OF LEVELSFROM MOLECULES AND CELLS TO TISSUES AND ORGANSIN RESEARCH ORGANISMS, HUMANS, AND POPULATIONS. ADDITIONALLY, TO ENSURE THE VITALITY AND CONTINUED PRODUCTIVITY OF THE RESEARCH ENTERPRISE, NIGMS PROVIDES LEADERSHIP IN SUPPORTING THE TRAINING OF THE NEXT GENERATION OF SCIENTISTS, ENHANCING THE DIVERSITY OF THE SCIENTIFIC WORKFORCE, AND DEVELOPING RESEARCH CAPACITY THROUGHOUT THE COUNTRY.

93.859 - Biomedical Research and Research Training

National Institute of General Medical Sciences (NIGMS) [HHS - NIH]

Morgantown, West Virginia 265052742 United States

Single Zip Code

IDeA Clinical Research Resource Center (U24 Clinical Trial Not Allowed) (PAR-22-150)

Amendment Since initial award the total obligations have increased 270% from $2,858,964 to $10,579,497.