Improving the New Clinical Trials Frontier

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Over the last decade rising global public health issues such as diabetes and obesity have had pharmaceutical and biotech companies, as well as physicians, racing to improve drugs and devices for patients. This healthy competition has given the globalization of clinical trials a big boost, and is fueling aggressive initiative in regions around the world. Recognition of stringent international guidelines is helping the global clinical trials industry surge forward, particularly in Latin America.

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Latin America is a magnet in the world of international clinical trials.  Qualified professionals and clinical research personnel from this region are constantly recruiting patients for clinical trials for new medication and devices working to reduce the prevalence of diabetes, obesity, cancer and cardiovascular disease rates.  And, there continues to be challenges for clinical trials in Latin America, such as coordination between the Food and Drug Administration (FDA), International Code of Harmonization (ICH) and local regulatory-harmonization guidelines, issues of transparency and accountability, adoption of electronic data capture, ethical review board surveillance, and the need for continuous professional education.

“In terms of regulatory issues it’s important that Latin America understand the need to have harmonizing practices from the two biggest regulatory agencies in the industry — the FDA and the ICH, which say how clinical trials are performed,” said Dr. Leonel Villa-Caballero, M.D., Ph.D., FACP, Director, Clinical Trials in Latin America program for UC San Diego Extension.

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The information and knowledge collected from studies performed in the Latin American region could also benefit some of the patient recruitment strategies on U.S. soil.  For example, there is a strong need for cultural competence among all researchers and clinicians who interact with Latino patients, according to Dr. Villa-Caballero. “Clinical and research professionals throughout the Spanish-speaking, and English-speaking world should be cognizant of cultural nuances in order to be sensitive to all patient needs during clinical trial recruitment as well as during and after trial completion.” “This will ensure a practical and appropriate adaptation to a particular region’s health as well as a culturally competent approach to research and honors the rights of individual patients”, Villa-Caballero further notes.

A clinical trials workforce in Latin America that respects the principles of cultural competence and ethical integrity, scientific innovation, biotech-pharmaceutical collaboration and academic excellence is the ideal situation.  Advanced professional education is a foundation of that goal: “There is a need for adequate education and scientific knowledge among health professionals trying to participate in clinical trials in Latin America,” Villa-Caballero said. “Both highly experienced and novice investigators would benefit from a program that reviews essential topics such as good clinical practices, ethics, monitoring and regulatory aspects in clinical trials that is tailored for the Latin American audience and offers hands-on experience that can be put to use in the workplace immediately.”

In addition, networking among private, public and academic healthcare institutions throughout Latin America, and if appropriate in collaboration with academic healthcare institutions in the United States, would enhance clinical trials in the region.

“We all can learn from one another, and approaches and results from trials world-wide, particularly in Latin America, need to be shared,” according to Villa-Caballero.  Building a “virtuous” cycle of clinical trials design, management and administration in Latin America is important.  This cycle includes trained and qualified personnel-sites which in turn encourage fast turnaround for new drug applications based on clear FDA inspections and audits, which constantly improve quality for a higher number of clinical trials revenues and productivity, which then offer the need for a more highly trained workforce…and the cycle continues.

Rigorous, academically-based professional education is the underpinning of this workforce.  Whether that education is in person, online, or a hybrid, it should offer practical, case-based learning from seasoned clinical and research professionals who have had experience in international clinical trials and can clearly explain all issues related to the drug development process, Good Clinical Practices (GCP), working with Contract Research Organizations (CRO’s), monitoring clinical trials, Institutional Review Boards (IRB’s), ethics, patient recruitment, starting a new clinical site, and regulatory practices appropriate for each country in Latin America.

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 villa-caballeroDr. Leonel Villa-Caballero, M.D., Ph.D., FACP, is the Director of the Clinical Trials in Latin America certificate program at UC San Diego Extension – a program focused on the Latin American region and presented entirely in Spanish. He is a physician and clinical researcher with a background in Internal Medicine, Endocrinology-Metabolism and Public Health. He has worked as Investigator and Co-Investigator in clinical research studies in the United States and Mexico and is currently a researcher in Family and Preventive Medicine at the UCSD School of Medicine. His interests are in diabetes, obesity and cancer prevention, particularly in using culturally-appropriate interventions for English and Spanish-speaking Latinos living in the United States. Dr Villa–Caballero has also served as advisor for private pharmaceutical companies in the areas of diabetes, obesity and cultural competency.

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