Ensaios clínicos: Capacitação nacional para avaliação de medicamentos e vacinas

Abstract

This paper presents an analysis of the capability of Brazilian clinical research centers to evaluate drugs and vaccines in the process developing new products. It uses public databases to quantify the trials, and interviews with sponsors and research centers to assess the competencies involved in their performance. It concludes that Brazilian capability in phases II, III and IV - specially III - is high, but the same does not apply to phase I trials. Capacity is higher in research execution than in design. These characteristics were developed in response to the demands of pharmaceutical multinationals, dominant in the past few years. Brazilian producers have demand specificities, such as trial design competence, that research centers will have to adjust to, if national demand grows, either through government-funded technological evaluation studies (to support healthcare policies, as now emphasized by the federal government), or through new drug development projects, or even for the adjustment to drug policy legislation. As to generic drugs, national legislation created demand for bioequivalence and bioavailability trials that is not met by laboratories and research centers. Governmental actions are suggested to strengthen the sector.