From Diagnosis to Execution: A National Plan Proposal to Redesign Clinical Research in Brazil to Improve Cancer Care...

Brazil has substantial capacity to contribute to global clinical research, supported by its population size, epidemiological diversity, and the Unified Health System (SUS). Despite this potential, the country has been described in policy documents and stakeholder discussions as being underrepresented in international clinical trials, reflecting persistent regulatory, operational, and structural barriers. Law No. 14.874/2024 was discussed as representing a major regulatory milestone, although its impact depends on effective implementation and system-level coordination. This article is based on a structured, multistakeholder deliberative process conducted during the First Annual Clinical Research Meeting (Encontro Anual de pesquisa Clinica-in Brazilian Portuguese), held in Brazil in May 2025. The meeting convened 20 speakers from industry, research organizations, clinical investigators, public and private research centers, patient advocacy groups, civil society, and health policy. Discussions were organized through plenary sessions and thematic working groups. A qualitative synthesis was conducted after the meeting to identify convergent policy directions and areas of divergence. Key challenges identified during the deliberative process included regulatory predictability, taxation and importation of research supplies, mandatory post-trial access, underutilization of SUS, workforce constraints, logistical bottlenecks, regional inequities, and limited public trust. Convergent policy directions discussed by participants emphasized effective secondary regulation of Law No. 14.874/2024, digital transformation, stronger integration of clinical research within SUS, workforce professionalization, patient-centered trial designs, and differentiated approaches for rare diseases and priority populations. Strengthening Brazil's clinical research ecosystem was described by participants as requiring coordinated policy action, transparent governance, and sustained investment. The policy directions synthesized here, derived from multistakeholder deliberation, are intended to inform regulatory development and institutional strategies rather than to serve as a formal consensus statement or implementation plan.