Puerto Rico To Leverage New FDA Guidelines And Promote New Leadership In Healthcare
Historically, minorities are underrepresented in medical trials, despite the fact that the findings can ultimately benefit these groups in particular. Crucial for gauging medical product safety and efficacy, medical trials should mirror the diversity of future users. However, according to Food and Drug Administration data, 75% of medical trial participants in 2020 were white; only 11% were Hispanic, 8% were Black, and 6% were Asian.
FDA’s Acknowledges Past Disparities, Creating A Possibly Brighter Future For Puerto Rico
Remarkably, even in innovation-oriented fields like medical research, diversity is lacking. In April, the FDA took substantial steps to increase racial and ethnic diversity in clinical trials, recognizing that the US population itself has become increasingly diversified. FDA Commissioner Robert M. Califf, M.D., highlighted the agency’s commitment to this new vision and its goal to develop better treatment strategies for diseases that disproportionately impact certain communities.
Puerto Rico, which is made up of many underrepresented communities, has leveraged the new standard set by the FDA and become the go-to center for companies and other organizations looking to conduct inclusive trials. Showcasing the symbiotic relationship between inclusivity and innovative research, it is setting a promising precedent by inviting researchers who seek to conduct diverse and personalized clinical trials, while at the same time enhancing the health of its populations.
This is also a strategic opportunity for financial growth. Last week, the Puerto Rico Consortium for Clinical Investigation (PRCCI) launched a new Clinical Research Center in San Juan. Since 2016, this non-profit organization has been launching innovation-based initiatives designed to advance the island’s economy and the well-being of its citizens. In addition, it has developed a large network of professionals, made up mostly of Puerto Rico natives, who hold key positions in the U.S. healthcare arena. With the new center and recent FDA requirements, the organization can accelerate its efforts to become the go-to location for clinical studies.
“We hope to become the preferred partner for the implementation of clinical trials.” Dr. Amarilys … [+]
Dr. Amarilys Silva, PRCCI’s Executive Director, is confident this new center will be a game changer not only for the island but for the global community as well. “We hope to become the preferred partner for the implementation of clinical trials,” she said.
According to Dr. Silva, the diverse Puerto Rico population enables the study of the effects of medical intervention across different genetic and ethnic groups, ensuring effective treatment across a broader demographic while meeting the new FDA standard. “The concentrated geography of Puerto Rico facilitates efficient participant recruitment and enrollment, shortens study cycles and reduces logistical costs. With our well-established infrastructure and the addition of our new research center, we now offer unparalleled resources for conducting trials.”
Alignment with U.S. FDA requirements simplifies the regulatory process for researchers and sponsors. “Puerto Rico is setting a pathway for global medical innovation in clinical studies for diverse communities,” says Dr. Kenneth Ramos, Chairman of the Board of Directors of PRCCI. Ramos is a known specialist in precision medicine and is affiliated with the Texas Medical Center in Houston. “Our established clinical studies ecosystem represents a viable alternative within the FDA’s strict safety and monitoring parameters.”
The Financial Differentiator
Puerto Rico is already a significant contributor to the pharmaceutical industry, with more than half of all manufacturing in the country, i.e., $60B, attributed to the pharmaceutical industry. The industry generates over 18,000 jobs, pays over $3 billion in taxes, and comprises about half of total exports, contributing more than 25% to the island’s GDP.
During the inauguration ceremony of the Center, the organization shared the results of an economic study commissioned by the Puerto Rico Science, Technology and Research Trust and PRCCI, and conducted by research economist and data scientist Dr. Mario Marazzi. The study demonstrates the strength of this sector on the island and reveals that the clinical trial market generated $27.5 million in the fiscal year 2020-21 in direct costs. Taking into account indirect expenses, it reflects a total of $50 million annually in economic activity for Puerto Rico.
Dr. Kenneth Ramos, Chairman of the Board of Directors of PRCCI launching the new center last week.
Innovation-Leading Demographics Additionally, Dr. Silva explains that conducting trials locally enables researchers to address specific health disparities and unique challenges of the population. The clinical trials being performed on the island these days focus on therapeutic solutions in fields of oncology, endocrinology, infectious diseases, and gastroenterology, similar to research in the U.S.
Out of a population of 3.26M Puerto Ricans, 59% are considered white (Hispanic), 18.6% belong to the category of other (Hispanic); 11.2% are black or AA (Hispanic); and 9.62% are multiracial (Hispanic). Studies have shown that the average Puerto Rican is about 64% European, 21% African, and 15% Native Taino.
The Unique Position of A U.S. Territory
Dr. Silva addresses the multiple advantages of conducting clinical studies at this time in Puerto Rico as compared to the U.S. “As a U.S. territory, the island is subject to the same regulatory framework as the United States. Clinical trials in Puerto Rico are regulated by the FDA under the same guidelines as trials conducted on the U.S. mainland. However, the population is ethnically diverse here, which is ideal given the new interest in studying the impact of medications or treatments on different ethnic or racial groups.” She also points to the island’s infrastructure, and the network of research institutions, hospitals, and clinics directly connected to the new center. She notes another main advantage, the actual recruitment potential. “Puerto Rico’s relatively high population density and established healthcare system make it a viable location for participant recruitment in clinical trials.”
Silva is confident the center will soon be able to facilitate up to 10 studies at the same time, and at least five by the end of this year. The center currently invites proposals for studies from global companies. Every study will be assessed with the help of the Yale University Research Department. PRCCI will prioritize studies reflecting unmet needs on the island.