Health 360x Clinical Research Platform for Scalable Access to Clinical Trials

Lack of participation of African-Americans, Latinx communities and rural populations leads to persistent health disparities. The National Academy of Medicine, and research organizations have sounded the alarm about the impact on the clinical trial enterprise, and the health of Americans in general. The national Academy recommends strategies that will increase access to clinical research at the point of care. The COVID-19 public health pandemic has revealed significant health disparities affecting America’s black and brown communities, with 2.4 to 7 times mortality rates compared to white Americans. Current vaccine trials have enrolled less than 10% Blacks. This experience mirrors numerous NIH studies across institutes and centers, as well as industry studies. The goal of this SBIR Fast-Track proposal is to develop the knowledge, products and processes needed to implement Health 360x Platform Service in real world practices serving predominant African Americans, Latinx, and patients from rural communities.We will implement the following aims: 1)Specific Aim 1-Phase I. Design Health 360x Clinical Research Platform (Health 360x) 2) Specific Aim 2-Phase II. Test the feasibility of implementing Health 360x SOP in the workflow of three practices, serving under-represented patients. 3)Specific Aim 3-Phase II. Evaluate the adoption, implementation, effectiveness, and maintenance of Health 360x in practices serving under-represented patients Primary outcome: Adoption and implementation progress of Health 360x with performance indicators based on the CVIS Registry protocol; IRB/informed consent; PhenX surveys for social determinants; Recruitment and Retention rates; Cost analysis. This Fast-Track SBIR project will directly address NCATS priority on research efficiency by implementing a commercially viable clinical research platform that adapts to community practice settings, and is scalable, to recruit, track and retain patients who are under represented in biomedical research.