Wednesday, April 25, 2018

Can Puerto Rico become a hub for clinical research?

By on April 16, 2018

Editor’s note: This story first appeared in the April 12-18, 2018, issue of Caribbean Business.

With more than a decade under a recession, as well as severe austerity measures and damages from hurricanes Maria and Irma, the Puerto Rico economy is fighting its way to a path of growth. While there are many areas to consider for possible growth, the Puerto Rico Consortium for Clinical Investigation (PRCCI) is betting that the promotion and expansion of the island as a hub for clinical trials is a positive route for the economy, doctors and patients in Puerto Rico.

To that end, the PRCCI is preparing for the Puerto Rico Clinical Research Summit on May 9. This summit will include “all relevant stakeholders for clinical research—the FDA [Food & Drug Administration], patients, investigators, sponsors and pharmaceutical companies—to showcase our capabilities,” explained Kosmas Kretsos, executive director of the consortium.

The summit will serve as an opportunity to correct any perception problems Puerto Rico has a research destination, as well as serve to promote integration among the different research components, including patients’ point of view. However, promoting Puerto Rico as a research destination needs to go beyond perceptions since it also involves educating and incentivizing patients and medical professionals to join with this sector.

How do we measure up?

When it comes to comparing Puerto Rico with other U.S. jurisdictions, the island “has room for growth,” Kretsos argued. He explained that as a research destination Puerto Rico is not as “mature” as states such as California, Texas or Florida that for decades have prioritized clinical research.

The States’ focus on attracting clinical trials has shown positive economic indicators in an expanding portion of the economy.

A 2015 study by Battelle Technology Partnership Practice for Pharmaceutical Research & Manufacturers of America, showed that biopharmaceutical companies spent $10 billion in 2013 on more than 6,000 U.S. clinical trials. However, the study also concluded the actual economic impact from clinical trials that year was $25 billion generated.

The states with the biggest windfall were California, Texas, Florida, New York and Pennsylvania. California saw a direct investment of $1.1 billion a projected economic impact of $3 billion. Texas and Florida saw direct investment of nearly $1 billion and an economic impact of about $2.6 billion and $2.7 billion, respectively.

Kretsos also highlighted these three states because they are comparable to Puerto Rico in terms of their demographic diversity, which is a desired feature for pharmaceutical companies conducting clinical trials. Because many other jurisdictions lack this diversity, Puerto Rico has a better clinical base for pharmaceutical companies to do their studies on the island, the PRCCI director argued.

“Right now, if you look at statistics, for the most part we are developing drugs for Caucasians [with white European ancestry], which means we know the [medications] work and are safe for Caucasians. We do not know exactly how effective they are for Latinos,” Kretsos stated.

Kretsos reiterated the importance of Puerto Rico being a Latin American as well as U.S. jurisdiction because the island provides research data about the Hispanic demographic under FDA guidelines.

Kretsos is not the only researcher highlighting this mix. Dr. Oscar Soto, who runs Mindful Clinical Research, and Dr. Gregorio Cortés, who operates CGM Medical Group, argue that pharmaceutical companies seeking their services also see this benefit. Furthermore, Soto explained that companies sometimes come to his center to conduct multicenter studies, which means the clinical trials run in various parts of the U.S. or the world.

Another factor in which Puerto Rico has positive research results is in patient recruitment and retention, the three professionals argued. Soto explained that while there may at first be some reservations, patients who participate in clinical trials in Puerto Rico tend to have a positive experience.

–Read the rest of this article in Caribbean Business’ epaper here.

 

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