Puerto Rico Will Take Advantage Of New FDA Guidelines And Promote New Leadership In Healthcare
Historically, minority groups have been underrepresented in medical trials, despite the fact that the findings could ultimately benefit the group. Important to measure the safety and efficacy of medical products, medical trials should reflect the diversity of future users. But according to Food and Drug Administration (FDA) data, 75% of medical trial participants in 2020 were white; only 11% were Hispanic, 8% black, and 6% Asian.
Remarkably, even in an innovation-oriented field such as medical research, diversity is lacking. In April, the FDA took substantial steps to increase racial and ethnic diversity in clinical trials, acknowledging that the US population itself had become increasingly diverse. FDA Commissioner Robert M. Califf, MD, 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 taken advantage of the new standards set by the FDA and is becoming a center of attention for companies and other organizations looking to conduct inclusive trials. By demonstrating the symbiotic relationship between inclusivity and innovative research, the company is setting a promising precedent by inviting researchers seeking to conduct diverse, personalized clinical trials while improving public health.
It is also a strategic opportunity for financial growth. Last week, the Puerto Rico Consortium for Clinical Investigation (PRCCI) launched a new Center for Clinical Research in San Juan. Since 2016, this non-profit organization has launched innovation-driven initiatives designed to advance the island’s economy and the well-being of its citizens. In addition, they have developed an extensive professional network, consisting primarily of native Puerto Ricans, who hold key positions in the US healthcare sector. With the new center and the latest FDA requirements, the organization can accelerate its efforts to become a destination for clinical studies.
Dr. Amilys Silva, Executive Director of PRCCI, is confident that the new center will make a difference not only for the island but also for the global community. “We hope to become the partner of choice in conducting clinical trials,” he said.
Silva, Puerto Rico’s diverse population enables studies of the impact of medical interventions on different genetic and ethnic groups, ensuring treatment is effective in a wider demographic while meeting new FDA standards. “Puerto Rico’s concentrated geography facilitates efficient recruitment and enrollment of participants, shortens study cycles, and reduces logistical costs. With our established infrastructure and the addition of a new research center, we now offer unparalleled resources to conduct trials.”
Alignment with US FDA requirements simplifies the regulatory process for researchers and sponsors. “Puerto Rico is setting the path for global medical innovation in clinical studies for diverse communities,” said Dr. Kenneth Ramos, Chair of the PRCCI Board of Directors. Ramos is a renowned specialist in precision medicine and is affiliated with the Texas Medical Center in Houston. “Our well-established clinical study ecosystem represents a viable alternative within the FDA’s stringent monitoring and safety parameters.”
Financial Differentiator
Puerto Rico has been a significant contributor to the pharmaceutical industry, with over half of all manufacturing in the country, namely $60 billion, attributable to the pharmaceutical industry. The industry creates more than 18,000 jobs, pays more than $3 billion in taxes, and accounts for about half of total exports, and contributes more than 25% to the island’s GDP.
At the Center’s inauguration ceremony, the organization shared the results of an economics 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 2020-21 fiscal year in direct costs. Taking into account indirect spending, this figure reflects a total annual economic activity of $50 million in Puerto Rico.
Demographics Leading in Innovation In addition, Dr. Silva explains that conducting trials locally allows researchers to address specific health gaps and unique challenges facing communities. Clinical trials being conducted on the island are currently focused on therapeutic solutions in oncology, endocrinology, infectious diseases, and gastroenterology, similar to studies in the US.
Out of a population of 3.26 million Puerto Ricans, 59% are considered white (Hispanic), 18.6% fall into the other category (Hispanic); 11.2% were black or AA (Hispanic); and 9.62% were multiracial (Hispanic). Research shows that the average Puerto Rican population is about 64% European, 21% African, and 15% indigenous Taino.
US Territory Unique Position
Dr. Silva discussed the various advantages of conducting current clinical studies in Puerto Rico compared to the United States. “As an American territory, this island is subject to the same regulatory framework as the United States. The clinical trial in Puerto Rico is regulated by the FDA under the same guidelines as trials conducted in the US mainland. However, the population here is ethnically diverse, which is ideal given the renewed interest in studying the effects of medication or treatments on different ethnic or racial groups.” He also mentioned the infrastructure of the island, and the network of research institutes, hospitals and clinics directly connected to the new center. He noted another key advantage, the true recruiting potential. “Puerto Rico’s relatively high population density and well-established healthcare system make it a viable location for recruitment of participants in clinical trials.”
Silva believes the center will soon be able to facilitate up to 10 studies at the same time, and at least five studies by the end of this year. The center is currently inviting study proposals from global companies. Each study will be assessed with the assistance of the Yale University Research Department. PRCCI will prioritize studies that reflect unmet needs on the island.
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