ABSTRACT
This proposal seeks the establishment of the Puerto Rico Racial & Ethnic Minority Acceleration Consortium for
Health Equity (PR-REACH). This consortium aims to support the advancement of Hispanic Puerto Ricans
voices regarding perspectives, preferences, and unmet needs to FDA-approved medications and its outcomes,
by increasing the available knowledge of individuals from this underrepresented group. The creation of this
consortium (PR-REACH) is a first step in a research agenda to collaborate with the Food and Drug
Administration (FDA) Office of Minority Health and Health Equity (OMHHE) across REACH research projects
and activities. A training component is also sought that supports these by educating not only researchers, but
also patients, students, providers and providers in training. The proposal has two aims, first to build an
administrative research and communication infrastructure to support, collaborate and coordinate efforts
between PR-REACH and the FDA OMHHE. To this end a PR-REACH leadership team, three research cores,
a training and mentoring core, and an advisory team will be created to: 1) employ innovative strategies,
trainings, education, and communication methods to understand Puerto Rican individuals preferences,
experiences and unmet needs regarding FDA approved treatments and medications, 2) leverage big data,
machine learning and artificial intelligence data analysis and local health data sources in PR to be able to
evaluate the safety and efficacy of FDA-approved products (therapeutics, diagnostics, and vaccines) and
products subject to EUAs/EUA expansion, and 3) identify barriers to clinical trial enrollment for Hispanic Puerto
Ricans and develop innovative strategies to address such barriers. Finally, a pilot study under this consortium
will be conducted (aim 2) to advance the understanding of substance use disorder patients’ journey as
perspectives, preferences and unmet needs regarding substance use disorder (SUD) treatment with FDA
approved medications in PR to be able to improve its outcomes. The PR-REACH will initiate with Hispanics
living in Puerto Rico as a model than can inform and guide subsequent extrapolation to Hispanics in the US.
These activities will be conducted in a 2-year period.