New consortium supports clinical research in struggling Puerto Rico
Monday, May 16, 2016
A newly established consortium aims to enhance and promote clinical research and drug development in Puerto Rico. It is hoped that the consortium will combat declining clinical trials in the region to benefit patients, the Puerto Rican economy and global science.
Established in April, the Puerto Rico Consortium for Clinical Investigation (PRCCI) is a nonprofit cooperative of academic and private research sites. The goal of PRCCI is to support best practices, improve and standardize quality, share knowledge and promote the success of clinical trials on the island.
PRCCI is working to improve the impact, quality and speed of clinical research in Puerto Rico through a collaborative network of investigators, by establishing best practices for the conduct of clinical trials and by educating sponsors and researchers. The consortium was developed by the Puerto Rico Science, Technology and Research Trust (PRSTRT), whose overall strategy is to transform Puerto Rico into a knowledge-driven economy.
Kosmas Kretsos, Ph.D., PRCCI executive director, said there is great potential for much-needed clinical research in Puerto Rico. “Clinical research has well-documented societal and economic benefits,” he said. “Sadly, Puerto Rico is experiencing rough times economically, and key professionals are leaving the island to find better opportunities in mainland U.S. By enhancing and promoting clinical research, we can help retain these professionals.”
Kretsos said the combined strength of the consortium’s members provides large breadth and depth in therapeutic expertise and allows for studies in any phase and at multiple sites seamlessly. “We know that quality and speed of execution are paramount,” he explained. “We proactively monitor and improve quality and performance within our sites in adapting industry standards. We leverage our expertise, centralize site selection and offer a central point of contact for sponsors and CROs.”
Anyone who wants to join the consortium and add clinical trials will have to pass a very rigorous onboarding process. There is a quality monitoring process that happens on a trial-by-trial basis. Ultimately, the goal is that the quality would improve throughout all sites in the consortium.
Early mainland-U.S. partners of PRCCI include The Clinical Research Group (TCRG) and PharmaSeek, which has had a presence in Puerto Rico for more than five years, working with four sites there. “One of the things that intrigued us about the partnership is that the consortium is really focusing a lot of attention on both the consistency and the quality side,” said Nicolas Cindric, chief executive officer of PharmaSeek.
PharmaSeek is working to share knowledge and core competencies with research sites aligned with the consortium, to help build and grow the network. In addition to study identification, PharmaSeek is providing assistance with site feasibility, contract and budget negotiation and accounts receivable.
Cindric points out that Puerto Rico is unique because unlike most Caribbean islands, Puerto Rico can submit to both the U.S. FDA and the Latin America regulatory agency. “If you’re a pharmaceutical company doing research and you’re trying to develop results for each of those institutions, the work that was done in Puerto Rico can be submitted for approval from both agencies. That part is an attractive differentiator for Puerto Rico.”
Jill Shilbauer, director of Network Operations for the PharmaSeek resource based in San Juan, said education and training is a major component of the initiative. “One aspect of PRCCI is to educate our clinical trials staff and make sure they have opportunities to grow their knowledge base and share it with others,” she said. “That’s really important from the overall perspective of improving the standards, while offering opportunities for individuals who live in Puerto Rico to explore a new career path.”
Fundación de Investigación (FDI), a clinical research center based in San Juan that has successfully completed hundreds of FDA-regulated clinical trials, has committed to partnering with PRCCI to share expertise and support efforts to broaden research opportunities, said Michelle Echeandia, FDI’s chief operations officer and quality control co-director.
“We’re helping this consortium by giving them ideas about things we have done successfully and what we can do in Puerto Rico in terms of research for all phases, from healthy volunteer studies to bioequivalent studies,” Echeandia said. “We have all of these capabilities. We just need to train people and motivate young physicians to become great investigators.”
Echeandia believes the consortium’s efforts will help stimulate the economy, create jobs and support public health. “Clinical trials need our patient population to be part of the statistics,” she said. “Some people think Puerto Rico is on the other side of the world, but we are part of the U.S. and go by the same FDA guidelines. We don’t have to use any other IRBs; we can work with all the central IRBs that the sponsors have.”
This week, researchers from Yale University will visit Puerto Rico to explore joint research opportunities. PRCCI’s five-year strategy is to develop a clinical research hub followed by a regional center of excellence for clinical research.
“Puerto Rico is a U.S. territory, but the U.S. government is at a crossroads as to what to do to help with their financial issues,” Cindric said. “This type of initiative, along with some other things they’re trying to do, can help make them more self-sufficient.”
Altruism is a significant factor for those involved in the consortium. Kretsos said, “For us, the societal benefits are more important. Through clinical research, you have more treatment options, which is important for the people of Puerto Rico, and they also benefit the whole world by volunteering to help develop better and safer drugs.”
This is primarily for the greater good of the entire Puerto Rican economy. It helps by increasing the quality and the training at sites, making them better, helping small businesses in Puerto Rico grow.
This article was reprinted from Volume 20, Issue 19, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »