Recruiting patients for clinical trials can be a tough endeavor no matter which population you are targeting. But a recent article in CenterWatch brought to light the challenges in recruiting the Latino and Hispanic populations, stating it can be especially difficult – though they represent 16% of the U.S. population, Latinos and Hispanics constitute only about 3% of the approximately 260,000 Americans who volunteer to participate in medical research each year.

With the FDA encouraging sponsors to recruit subjects representative of the U.S. population, it’s important to understand the biases and fears among these communities when it comes to trial participation. While the FDA has not mandated any specific requirements yet, it’s best to be fully prepared.

Sandra Grosworsel Schefler, Managing Director of Clinipace Worldwide, Brazil, notes the trend for clinical trials being held outside of U.S. creates the perception for emerging countries that U.S. citizens won’t participate in their own trials; a major red flag.

To further understand the lack of participation in clinical trials by the Latin American community in the U.S., I feel it is best to start with defining those considered members of Hispanic-Latino community. By definition, it should include all those belonging to the American Continent (except from the U.S. or Canada), plus those coming from EU countries with Latin roots like Spain, Portugal and Italy. However, it’s not just about origin.

  • Culture: Clinical research is still developing in Latin America. Many come from countries where the socio-economical conditions are poor with limited education. Common misconceptions include being treated as a “guinea pig” – which is not exclusive to the Hispanic community in the U.S., but also a common misconception everywhere. Language barriers also play a role. Confidence is essential for any patient to participate in a clinical trial. If a patient cannot understand the process, they’re less likely to be involved.
  • Tradition: Tied closely to the Latin American culture is family and tradition. Older family members can be very protective and hold a lot of sway over younger generations, even those who are completely integrated into American culture.
  • Fear: First-generation immigrants who are in the U.S. illegally fear that if they sign up for a trial, they’ll be turned in. Fear of being deported, fear of loosing acquired rights, and fear of misunderstanding what they are committing to or accepting play a big role in the lack of participation.

Both Sandra and I agree the best tool to improve this situation is through education, and not just to the Latin American community, but also worldwide. There needs to be more transparent communication on the good, the bad, the pros and the cons of clinical trial participation – with an emphasis on safety measures and patient protection.

Is it the responsibility of the pharma/healthcare/biotech/CRO community leaders to take action and improve the current landscape by holding more meetings and forums to discuss and demystify clinical trials among the Latin American community? Or does the job lie back in the hands of the FDA and other regulatory organizations? Don’t look to government to solve this issue, it’s simply not their job!