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e23038 Background: Latin America (LATAM) represents 8.4% of the world's population and has a growing cancer incidence compared with other regions. However, most clinical trials are conducted in high-income countries. The clinical research regulatory regimen in LATAM has been evolving consistently in the last decade and now is stable and mature, and data quality is comparable to other geographies. Enhanced LATAM involvement in global clinical trials would help these studies to meet recruitment goals, increase diversity, and reduce costs and perhaps timelines associated with clinical research. This abstract shows the current landscape of clinical research in LATAM trough data and experience of a global clinic research organization (CRO) (Fortrea). Methods: We obtained the 2020 cancer incidence in Brazil, Mexico, Argentina, Chile, Peru, Colombia, LATAM, and worldwide, from the World Health Organization’s GLOBOCAN database, as well as the information about ongoing, terminated, or completed clinical trials in these regions using Citeline’s database, from 2018 to 2023. We gathered LATAM countries' regulatory approval timelines from Fortrea’s database. Results: Overall, 7.7% of all cancer cases in 2020 were diagnosed in LATAM; however, only 3.64% of oncology trials were conducted there. The major disparities are in prostate cancer (15.2% vs 3.9% of cases and trials, respectively), followed by thyroid (10.8% vs 3.7%), cervix uteri (9.8% vs 4.6%), leukemia (8.1% vs 3.6%), and colorectal (7% vs 2.51%). Brazil had 3.1% of all cases but 1.9% of trials, while Mexico had 1% vs 1.3%, Argentina had 0.7% and 1.3%, Chile had 0.3% vs 0.7%, Peru had 0.4% vs 0.6%, and Colombia had 0.6% and 0.45% respectively. Regarding trial phases, 0.7% of Phase I trials were run in LATAM, 2.2% of Phase II, 15.6% of Phase III, and 2.8% of Phase IV. In the Table below, we present the proportion of clinical trials in LATAM in the past 5 years, based on the actual enrollment first date. Regulatory approval timelines in LATAM vary among countries, being 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia, 2.8 months in Mexico, and 9 months in Peru. Conclusions: As a region, LATAM has been underrepresented in the clinical research scenario in the past five years, including in much-needed areas like prostate, colorectal, and cervical cancer. It is better represented in phase III studies but has almost negligible participation in other trial phases. There are differences among individual countries, with Brazil being underrepresented as opposed to Argentina and Mexico. Start-up timelines are variable among countries but overall comparable to other regions. We notice a significant potential to increase the number of clinical trials in LATAM. Table: see text
Filho et al. (Sat,) studied this question.