Impact of Law 14,784/24 on Clinical Research in Oncology

Abstract

Brazil sparks international interest in clinical research due to its population diversity, epidemiological profile, strategic geographic location, quality of the generated data, recruitment potential and participants retention, with oncology being the main therapeutic area of the clinical trials in the country. However, the slowness of the regulatory process presents challenges that affect the execution of international multi-centric studies, especially in early stages. It’s essential to rethink the regulatory model, seeking a balance between protection of participants and efficiency in carrying out clinical research. Law 14,784/24 represents a significant advancement for clinical research in Brazil, meeting demands of the scientific community for a regulatory framework. However, there are gaps and uncertainties that still need clarifying, such as the centralization of ethical analysis that weakens the autonomy of Research Ethic Committees of the participating centers, as well as the new rule of post-study access. Hopefully the benefits of the sanctioned law will overcome the challenges and promote an effective ethical-scientific environment for technological development in the country.