New medical treatments haven’t reached everyone equally. Why? A lack of diversity in clinical trials. African Americans make up 13% of the US population but only 5% of clinical trial participants. Similarly, Hispanics are vastly underrepresented, comprising 15% of the population but just 1% of trial participants. (1)
This disparity has real-world consequences. Treatments tested on homogenous groups may not be as effective or safe for everyone. The FDA recognizes this and issued updated guidance in 2022 urging the inclusion of diverse populations in clinical trials.
Curious Fact About Diversity in Latin American Clinical Trials
Latin America is one of the less exploited regions for patient recruitment compared to US and EU. Hence, conclusion here, is a tremendous opportunity to incorporate diversity in clinical trials.
Latin America has become one of the most attractive locations for international clinical trials.
Latin America supports about 10% of clinical research worldwide. The pharmaceutical industry invested approximately $980 million in clinical trials in Brazil, Argentina, and Mexico in 2019 (together representing 70% of the clinical trials in Latin America).
Latin America has over 650 million people; over 80% of them live in urban areas. Latin America is now the planet’s most urbanized region. (2)
Why is Diversity so Critical in Clinical Trials?
If trials only reflect a limited portion of the population, the results may not be applicable to everyone. This can lead to missed opportunities for some and potential safety risks for others.
Historically, minority communities have faced exploitation and mistrust in medical research. Increasing diversity fosters trust and encourages participation.
Diversity in Clinical Trials
Let’s explore how diversity is been implemented in clinical research.
Before 2016, collecting diversity data in clinical trials was limited. However, the FDA recognized the importance of inclusivity and acted. In 2016, they implemented a new approach requiring trial sites to ask two key questions about race and ethnicity. While a positive step, it offered a basic snapshot of participant demographics.
The FDA continued its efforts in November 2020 with the release of “Enhancing the Diversity of Clinical Trial Populations.” This comprehensive guidance went beyond data collection, outlining strategies to increase participation from underrepresented groups, paving the way for more equitable access to clinical trials.
Building on this progress, the FDA issued a draft guidance in April 2022 titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” This guidance directly advises sponsors of medical products to develop specific Racial and Ethnic Diversity Plans for their studies.
Among the most relevant points to note about this latest update are:
- Creating Diversity Plans: Sponsors are encouraged to develop Race and Ethnicity Diversity Plans to include underrepresented populations in clinical trials better.
- Holistic Planning: Sponsors should incorporate diversity strategies, including design and enrollment practices, from the start of the trial process.
- Clear Recommendations: The guidance provides detailed advice on setting enrollment goals, identifying participation barriers, and developing strategies to overcome them.
- Monitoring Progress: Sponsors should regularly check and report on their progress toward their diversity goals to ensure accountability.
- Accessible Trial Designs: Sponsors are urged to design trials that are easier for diverse populations to join, potentially through decentralized trials and flexible scheduling.
- Community Engagement: Building trust and awareness in underrepresented communities involves partnerships with local organizations.
- Ethical Standards: Following regulatory and ethical guidelines when developing and implementing diversity plans is essential.
- Broad Impact: The goal is to make clinical trial results more applicable to a broader range of people, improving health outcomes for everyone.
Read the full FDA Guide Here.
For more than 10 years, Integra IT has been a leading force in Latin American clinical research. We don’t just expand clinical research globally, we champion diversity, inclusion, and cutting-edge technology in clinical trials throughout Latin America and emerging markets.
References:
(1) Reopell, L., Nolan, T. S., Gray, D. M., II, Williams, A., Brewer, L. P., Bryant, A. L., Wilson, G., Williams, E., Jones, C., McKoy, A., Grever, J., Soliman, A., Baez, J., Nawaz, S., Walker, D. M., Metlock, F., Zappe, L., Gregory, J., & Joseph, J. J. (2023). Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions—A report from the “Health Equity through Diversity” seminar series. PLoS One, 18(2), e0281940. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9934412/
(2) Clinical Leader. (2023). Latin America: A Compelling Region to Conduct Your Clinical Trials. https://www.clinicalleader.com/doc/latin-america-a-compelling-region-to-conduct-your-clinical-trials-0001
