Desenvolvimento de guia para ensaios clínicos de medicamentos
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Data
2019-01-28
Autores
Oliveira, Bruna Mariotto Tavares de
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
Pode-se definir a Pesquisa Clínica como qualquer investigação científica realizada em seres humanos, com o intuito de descobrir ou verificar os efeitos farmacodinâmicos, farmacocinéticos, farmacológicos, clínicos e outros possíveis efeitos dos produtos investigados, além de avaliar sua segurança e eficácia, que poderão contribuir para o registro ou a alteração deste junto à Agência Nacional de Vigilância Sanitária (ANVISA). A Medicina Baseada em Evidências (MBE) veio preencher a lacuna com os conceitos fundamentais da Medicina e da Saúde de requererem evidências de eficácia, efetividade, eficiência e segurança para nortear decisões, tendo-se assim maiores probabilidades de acerto. Pelo lado econômico, a Pesquisa Clínica pode constituir uma alternativa para as empresas farmacêuticas nacionais competirem no terreno da inovação, por meio de estratégias menos custosas e arriscadas, como o desenvolvimento de novos medicamentos associando moléculas já no mercado, novos usos para medicamentos, entre outras. Vários medicamentos apresentam faturamento maior para indicações terapêuticas diferentes daquela para a qual foram originalmente aprovados. Mais da metade dos novos medicamentos aprovados pelo FDA no período compreendido entre os anos de 1989 e 2000 foram moléculas conhecidas com algum tipo de modificação ou forma farmacêutica diferente. Dentre as pesquisas envolvendo seres humanos, os ensaios clínicos são os que necessitam de maior cuidado do ponto de vista ético, pois se caracterizam por intervenção seguida de avaliação prospectiva de grupos de indivíduos. Podem ser terapêuticos, testando a eficácia de drogas, ou profiláticos, testando a eficácia de vacinas ou medidas de prevenção primária. No caso de novas drogas ou vacinas, a progressão para as fases de avaliação em seres humanos deve ser precedida de estudos experimentais in vitro e em animais, visando a esclarecer pontos importantes relacionados à eficácia e toxicidade potencial. Neste contexto, o presente trabalho pesquisou as normas para desenvolvimento de ensaios clínicos entre as agências de regulação mundiais " Food and Drug Administration - FDA" (EUA), " European Medicines Agency - EMA" (Europa) e "Agência Nacional de Vigilância Sanitária - ANVISA" (Brasil) para desenvolvimento e disponibilização de um guia para ensaios clínicos direcionado a pesquisadores clínicos.
Clinical Research may be defined as any scientific research carried out on human beings in order to discover or verify the pharmacodynamic, pharmacokinetic, pharmacological, clinical and other possible effects of the investigated products, and to evaluate their safety and efficacy, which may to contribute to the registration or alteration thereof with the National Agency of Sanitary Surveillance (ANVISA). The Evidence-Based Medicine came to crown the fundamental concepts of Medicine and Health requiring evidence of efficacy, effectiveness, efficiency and safety to guide decisions, and thus more likely to be successful. On the economic side, Clinical Research may be an alternative for national pharmaceutical companies to compete in the field of innovation through less costly and risky strategies, such as the development of new drugs by linking molecules already on the market, new uses for medicines, among others . Several drugs have higher billing for therapeutic indications different from the one for which they were originally approved. More than half of the new drugs approved by the FDA in the period between 1989 and 2000 were known molecules with some kind of modification or different pharmaceutical form. Among the researches involving human beings, the clinical trials are those that need greater care from the ethical point of view, since they are characterized by intervention followed by prospective evaluation of groups of individuals. They can be therapeutic, testing the effectiveness of drugs, or prophylactics, testing the effectiveness of vaccines or primary prevention measures. In the case of new drugs or vaccines, the progression to the evaluation stages in humans should be preceded by experimental studies in vitro and in animals, in order to clarify important points related to efficacy and potential toxicity. In this context, the present study aims to compare standards for the development of clinical trials between the Brazilian, American and European regulatory agencies, with the aim of developing guidelines for clinical trials aimed at clinical researchers wishing to break down national barriers to drug development.
Clinical Research may be defined as any scientific research carried out on human beings in order to discover or verify the pharmacodynamic, pharmacokinetic, pharmacological, clinical and other possible effects of the investigated products, and to evaluate their safety and efficacy, which may to contribute to the registration or alteration thereof with the National Agency of Sanitary Surveillance (ANVISA). The Evidence-Based Medicine came to crown the fundamental concepts of Medicine and Health requiring evidence of efficacy, effectiveness, efficiency and safety to guide decisions, and thus more likely to be successful. On the economic side, Clinical Research may be an alternative for national pharmaceutical companies to compete in the field of innovation through less costly and risky strategies, such as the development of new drugs by linking molecules already on the market, new uses for medicines, among others . Several drugs have higher billing for therapeutic indications different from the one for which they were originally approved. More than half of the new drugs approved by the FDA in the period between 1989 and 2000 were known molecules with some kind of modification or different pharmaceutical form. Among the researches involving human beings, the clinical trials are those that need greater care from the ethical point of view, since they are characterized by intervention followed by prospective evaluation of groups of individuals. They can be therapeutic, testing the effectiveness of drugs, or prophylactics, testing the effectiveness of vaccines or primary prevention measures. In the case of new drugs or vaccines, the progression to the evaluation stages in humans should be preceded by experimental studies in vitro and in animals, in order to clarify important points related to efficacy and potential toxicity. In this context, the present study aims to compare standards for the development of clinical trials between the Brazilian, American and European regulatory agencies, with the aim of developing guidelines for clinical trials aimed at clinical researchers wishing to break down national barriers to drug development.
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Guia de estudo, Materiais de ensino, Medicamentos, Ensaios clínicos, Study guide, Teaching materials, Clinical trials, Drug