Clinical Trials: Brazilian capability to evaluate drugs and vaccines

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.O trabalho apresenta uma análise da capacitação dos centros de pesquisa clínica brasileiros para realizar ensaios voltados para a avaliação de medicamentos e vacinas, como suporte ao desenvolvimento de novos produtos. Utiliza bases de dados públicas para a quantificação dos ensaios realizados e entrevistas com patrocinadores e centros de pesquisa clínica para a análise das competências envolvidas na sua realização. Conclui que, embora a capacitação nacional seja alta na realização de ensaios na fase III e razoável nas fases II e IV, ainda é incipiente na fase I, na qual existem poucos centros com experiência. É maior na execução da pesquisa do que no seu desenho. Este perfil foi forjado em resposta à demanda das multinacionais farmacêuticas, majoritária nos últimos anos. Entretanto, é diferente daquele demandado pelos empreendimentos nacionais, que inclui competências no desenho do ensaios, e precisaria ser ajustado para atendê-los, no caso da demanda nacional aumentar, seja por estudos de avaliação tecnológica governamentais (para subsidiar a política de assistência – área que está sendo enfatizada pelo governo federal), seja pelo desenvolvimento de novos medicamentos, seja até para a regularização da situação dos produtos similares atualmente no mercado. No caso dos medicamento genéricos e, mais recentemente, dos medicamentos similares, a regulamentação criou uma firme demanda por testes de bioequivalência e biodisponibilidade por parte das empresas nacionais. Poucos centros, entretanto, a estão atendendo: 78% dos estudos realizados em 2005 foram realizados por 5 dos 24 centros nacionais credenciados pela Anvisa para tal. São apresentadas propostas para o fortalecimento do setor94408424This 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 secto