Public Consultation SECTICS/MS No. 69/2025: Challenges and opportunities for strengthening clinical research in Brazil

Abstract

This study analyses data from the Public Consultation SECTICS/MS No. 69/2025, conducted by the Ministry of Health as part of an assessment of the current state of the clinical research ecosystem in Brazil. It is an observational study with both quantitative and qualitative approaches. Data collection took place from August 4 to September 18, 2025, through the Participa + Brasil platform. A semi-structured questionnaire with 65 questions organized into 10 thematic blocks was used. Of the 114 participants, most were from the Southeast and South regions. The main challenges identified were bureaucratic complexity and regulatory delays (85 mentions), insufficient funding (55), regional disparities in infrastructure (53), and a shortage of qualified professionals (52). The most frequently cited opportunities included regulatory improvement (65), training and capacity-building (47), digital integration (45), and strengthening research infrastructure. Criticism focused on the research ethics review system, particularly regarding the instability of the Plataforma Brasil. The findings indicate that the Brazilian clinical research ecosystem is undergoing consolidation, still marked by regional asymmetries, regulatory bottlenecks, and financial fragility.