Trust, ethics, and patient engagement in clinical research: Findings from the LACOG 1123 ASTRAL survey in Brazil.

Abstract

e23171 Background: Trust, ethical understanding, and engagement are critical determinants of successful and equitable clinical research. However, limited data describe how individuals with cancer perceive ethical safeguards, voluntariness, and their potential role in the design of clinical trials, particularly in middle-income countries. This analysis explored ethical perceptions, trust, and attitudes toward patient engagement in clinical research among Brazilian patients with breast cancer. Methods: ASTRAL (LACOG 1123) is a prospective, observational survey conducted among adults with breast cancer (stages I-IV) treated in public and private oncology centers in Brazil. Participants completed a structured electronic questionnaire assessing perceptions of research ethics, trust in institutions, understanding of voluntariness and data protection, and attitudes toward patient and community involvement in clinical trial design. Descriptive analyses and exploratory associations with educational level and healthcare setting were performed. Results: Among 350 respondents, most demonstrated positive perceptions of clinical research ethics despite knowledge gaps. While 66.1% were aware that clinical trials require approval by ethics committees, understanding of regulatory structures varied by educational level (p < 0.001). The majority agreed that participation in research is voluntary (77.1%) and that refusal would not compromise quality of care (74.5%). Trust in academic research information was higher than trust in pharmaceutical industry sources (58.3% vs 26.2%), while nearly half of respondents reported uncertainty regarding government protection against unethical research practices. Importantly, 66.0% supported active involvement of patients and community representatives in clinical trial design, prioritizing improved patient information (25.7%), facilitation of participation (18.0%), and contributing patient perspectives to study planning (34.5%). Concerns regarding privacy and data use focused primarily on understanding the purpose of data collection (64.5%) and who has access to personal information (30.8%), while the majority (81.5%) don’t known or don’t think that all clinical research results are all made publicly available. Conclusions: Brazilian patients with breast cancer report high trust in the ethical foundations of clinical research and strong support for patient and community engagement, despite incomplete understanding of regulatory frameworks and distrust regarding the clarity of available data, especially when the research is funded by industry or the government. These findings highlight an opportunity to strengthen participant-centered research by improving transparency, ethical education, and meaningful patient involvement in trial design, rather than focusing solely on recruitment strategies.