Clinical Research Action Plan in Brazil: analysis of its implementation process and main results, 2018-2025

This study evaluated the Clinical Research Action Plan in Brazil (PAPCB, acronym in Portuguese), established in 2018 by the Brazilian Ministry of Health. This ex post public policy evaluation study was based on documentary analysis for the 2018-2025 period. The six strategic axes of the PAPCB were considered: ethical regulation, sanitary regulation, scientific and technological promotion, training in clinical research, the Clinical Research National Network (RNPC, acronym in Portuguese), and knowledge management. The results showed significant advances in scientific promotion and professional training, with broad execution of the planned actions. The training of more than 45,000 professionals stands out in the training axis. The RNPC underwent restructuring, giving rise to the Brazilian Network of Clinical Research (RBPClin, acronym in Portuguese). However, structural challenges persist, such as the need to modernize Plataforma Brasil, improve knowledge management, and strengthen network collaboration. This study recommends the review and update of the PAPCB, incorporating strategies to overcome these gaps to consolidate the Brazilian scientific, technological, and institutional capacity in clinical research.

Keywords:
Clinical Study; National Science, Technology and Innovation Policy; Unified Health System