Breaking through barriers: Unraveling challenges in clinical trial participation among oncologic patients in a developing country.

Abstract

11144 Background: Clinical trials are vital for advancing cancer research and treatment development, yet obstacles to participation impede progress, particularly in regions with limited clinical research awareness, such as Brazil. Methods: This study was conducted in a single cancer center in São Paulo, Brazil, between 2020 and 2022. A tailored questionnaire comprising demographic (age, gender, income) and barrier-related sections explored patient-related (10 questions), protocol-related (7 questions), and physician-related (5 questions) barriers. Results: Among 206 oncologic patients enrolled in the study, 43.7% were from the public healthcare system, and 56.3% had private insurance. Patients who self-declared as white were 59.7%, and those who self-declared as brown/black were 35.9%. Patient-related challenges included unfamiliarity with trial participants (84.6%), concerns about daily life disruptions (75.4%), and transportation difficulties (66.2%). Protocol-related obstacles involved fears of unknown side effects (62.3%), inability to choose treatment (47.6%), and potential assignment to a placebo group (46.8%). Physician-related barriers included communication issues, strained doctor-patient relationships (94.7%), and patient deference to doctors' decisions (55.4%). Higher-income patients and those in the public health system demonstrated greater clinical research awareness. Conclusions: The study emphasizes the critical role of patient education in overcoming barriers to clinical trial participation in oncologic patients. Furthermore, it underscores the necessity of addressing disparities among minority populations, such as non-white individuals with lower incomes, to transform clinical research and ensure universal access to newer therapies. Efforts should be directed towards inclusivity, bridging awareness gaps, and fostering a comprehensive understanding of the benefits of clinical trial participation for all cancer patients.