Clinical Researcher—April 2024 (Volume 38, Issue 2)
INTERNATIONAL INTERLUDE
Amarilys Silva-Boschetti, PharmD
Clinical research is the cornerstone of medical progress, propelling innovations that transform healthcare landscapes. However, the imperative for inclusivity and diversity in clinical trials has only gained prominence in recent years. In this context, the Puerto Rico Consortium for Clinical Investigation (PRCCI) emerges as a beacon of progress, providing a unique and advantageous platform for researchers and sponsors seeking to enhance diversity in their studies.
Nestled in the heart of Puerto Rico, a vibrant U.S. territory with a cultural tapestry reflecting Hispanic, African, and Indigenous influences, PRCCI stands at the intersection of rich diversity and cutting-edge biomedical research. The organization has evolved over time, having transitioned from its roots as a consortium to establishing its own Clinical Research Center. This strategic expansion equips PRCCI with the capability to conduct independent trials, a particularly pertinent development given the U.S. Food and Drug Administration’s (FDA’s) endorsement and encouragement for organizations to initiate and conduct diverse clinical trials.
In April 2022, the regulatory agency released preliminary guidance titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” referred to as the Diversity Plan. The recommendation calls for sponsors to include a “Race and Ethnicity Diversity Plan” when submitting applications for investigational new drugs, biologics licenses, or investigational device exemptions.
Puerto Rico’s unique blend of cultures provides fertile ground for understanding how different populations respond to medical interventions. By conducting clinical trials in this environment, researchers gain access to a more nuanced understanding of how cultural factors may impact treatment outcomes. This cultural diversity extends beyond ethnicity, encompassing language, traditions, and healthcare beliefs, enriching the data and insights generated from clinical studies.
Additionally, thanks to its rich bioscience legacy of more than 65 years, the island stands out as an optimal partner for pharmaceutical and medical device companies seeking to conduct clinical trials. Renowned as the “Medicine Cabinet of the USA,” the island has played a pivotal role in the pharmaceutical industry, contributing more than $60 billion in manufacturing, creating more than 18,000 jobs, and accounting for approximately half of the country’s total exports. Furthermore, the island boasts a highly skilled labor force, with a strong emphasis on STEM education in both public and private academic institutions, producing more than 25,000 STEM graduates annually. Notably, the University of Puerto Rico Mayagüez campus serves as a top talent pool, with NASA consistently selecting more engineers from this campus than any other college in the United States.
PRCCI boasts a team of seasoned and skilled staff members and operates within the regulatory framework established by the FDA. As a U.S. territory, Puerto Rico adheres to the same rigorous regulatory standards, ensuring that clinical trials conducted at PRCCI meet the highest levels of quality and ethical practices. This regulatory alignment provides sponsors and researchers with confidence that their studies are conducted in a compliant and reputable environment.
In essence, Puerto Rico invites you to see beyond its tourist allure—it’s not merely a destination but a dynamic workplace, especially poised to revolutionize the landscape of inclusive clinical trials. With its customs-free operations, bilingual population, and scientific know-how, it stands as a paradise for researchers and sponsors seeking diversity in their trials.
Amarilys Silva-Boschetti, PharmD, is Executive Director of the Puerto Rico Consortium for Clinical Investigation, a subsidiary of the Puerto Rico Science, Technology & Research Trust, and has held diverse roles in research, medical affairs, global product safety/pharmacovigilance, and regulatory affairs.
