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FDA REQUIREMENTS FOR DIVERSITY INCLINICAL TRIALS: LATAM OPPORTUNITY

Updated: Mar 11

When developing a new drug, Clinical Trials and their phases are crucial to understanding the drug's safety profile, efficacy, and tolerability in a population who will benefit from the drug after launch, including a variety of subjects according to age, gender, and ethnicity.¹


In the last couple of years, the FDA has issued several communications to Sponsors and global CROs, expecting to increase awareness of its diversity plan and adjust the representativeness of different racial and ethnic populations in Clinical Trials. In April 2022, a guide was issued by the agency and a recent study shows that 94% of the trials’ population is composed of Caucasians/Others, 5% are African Americans, and 1% Hispanic. In contrast, the USA population, for example, is composed of 72% Caucasian/Others, 12% African Americans, and 16% Hispanic.² Due to this context and enrollment difficulties, Biotech companies have recently considered new regions for their clinical trials. Latin America (LATAM) has played a crucial role in developing new treatment options and helping companies comply with FDA requirements.


Underrepresentation in Clinical Trials












Ethnical Diversity


LATAM emerges as a solid option to develop Clinical Trials considering the FDA guide for

representativeness due to its large population, comprising over 500 million individuals from mixed ethnic groups and ages. For example, most of the population in major countries, Brazil and Mexico, are composed of African Americans (51%) and Hispanics (60%), respectively.³












Safety Profile









Another strategy being adopted by Sponsors is to consider the region on early-stage Clinical Trials(Phases I and II) to guarantee the results apply to different ethnic groups by benefiting from data onthe drug's safety profile. The Brazilian regulatory agency, ANVISA, an ICH board member, has recently published an analysis of Clinical Trials presence in the country, and comparing 2 021 to 2023, the number of Phase I trials increased by 66%, and Phase II trials increased by 60% in the same period.


Despite the rise in Phase I and II trials, sponsors and global CROs still see LATAM as an untapped opportunity. Of the interventional clinical trials registered in ClinicalTrials.Gov in 2022-2023 global the region is considered in only 3.4% of these trials.


New regulations to welcome sponsors


LATAM regulatory agencies are aware of the region's potential to receive new protocols and are investing in structuring new processes/regulations to welcome and promote innovation in healthcare. The Brazilian agency ANVISA, for example, has issued the RDC-205


regulation, granting a Fast-Track review process of 30 days for rare-diseases Clinical Trials. Another strategy the Sponsors are benefiting from is the Simplified Analysis for protocols already approved by another agency member of ICH, which is the case of FDA, EMEA, and Australia as examples, and also establishes a maximum of 30 days’ timeline for review. 


These regulatory strategies represent a crucial step towards creating an innovation ecosystem for healthcare by complying with FDA regulations, helping sponsors with fast approval timelines, increasing the quantity and diversity of enrollment, and offering quality data to innovative clinical trials.


"We can conclude that LATAM emerges as the destination for representativeness in clinical trials due to its etnical diversity and is investing in its processes to accelerate the approval timelines, matching the sponsor’s needs and expecting to become a new healthcare innovation hub."

Raissa Nogueira Bernardo, M.Sc cMSL





References

1-    INCA - Ensaios clínicos — Instituto Nacional de Câncer - INCA (www.gov.br) access in 12/Jan/2024

2-    National Academies of Sciences, Engineering, and Medicine; Policy and Global Affairs; Committee on Women in Science, Engineering, and Medicine; Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Bibbins-Domingo K, Helman A, editors. Washington (DC): National Academies Press (US); 2022 May 17. PMID: 36137057.

6-    Ministério da Saúde (saude.gov.br) access in 16/Jan/2024

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