Ensaios clínicos em Portugal e no contexto Europeu
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Data
2013
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A investigação clínica está na origem do desenvolvimento da ciência e do
conhecimento na área da saúde, e pretende explorar se uma estratégia médica, terapêutica ou um dispositivo é seguro e eficaz em humanos.
O desenvolvimento de um ensaio clínico envolve a coordenação e
cooperação entre várias entidades, principalmente a Autoridade competente, o
sponsor, o investigador e o Comité de Ética. É fundamental compreender o papel e a responsabilidade de cada uma destas entidades e o modo como estas interagem
entre si. Todo o processo desde o planeamento estratégico até ao desenvolvimento
do ensaio clínico encontra-se legislado por regulamentação bem definida, e
orientada sobretudo para a proteção dos direitos e bem-estar dos participantes e
para a obtenção de dados clínicos com elevada qualidade científica. Este
enquadramento regulamentar foi sendo desenvolvido ao longo do século XX, paralelamente à evolução do enquadramento ético.
Apesar da qualidade científica e ética proporcionada pelos países desenvolvidos, no século XXI começou a assistir-se a uma deslocalização dos
ensaios clínicos para países em desenvolvimento, nomeadamente a Ásia, América
do Sul e África. Tratam-se de regiões que envolvem populações vulneráveis e onde
os princípios éticos não assumem a mesma importância. Como consequência
verificou-se uma redução no número de ensaios realizados tanto a nível europeu
inclusive em Portugal. Perante tal, tornou-se imperativo fazer esforços no sentido de aumentar a atratividade da Europa como região para a realização de ensaios
clínicos. Estes esforços passam pela apuramento da legislação europeia, e
simultaneamente nacional, de modo a agilizar e a simplificar todo o processo de um
ensaio clínico e adequá-lo às necessidades atuais, sem reduzir a proteção dos
participantes. O âmbito do presente trabalho é dar a conhecer e clarificar de modo
abrangente a situação atual dos ensaios clínicos em Portugal e enquadrá-la no
contexto europeu.
The development of scientific and medical knowledge arose from clinical research, and its objective is to explore whether a medical strategy, treatment, or device is safe and effective for humans. The development of a clinical trial involves a coordination and cooperation between diferent entities, mainly the competent authority, the sponsor, the investigator and the ethics committee. It is essential to understand the role and responsibility of these entities and how they interact with each other. The entire process from strategic planning to the development of the clinical trial is legislated by well-defined rules, and primarily focused towards protecting the rights and welfare of participants and to obtain clinical data with high scientific quality. This regulatory framework was developed throughout the twentieth century, alongside the evolution of ethical framework. Despite the scientific and ethical quality provided by developed countries, in the twenty-first century we began to attend to a relocation of clinical trials to developing countries, particularly Asia, South America and Africa. These are regions that involve vulnerable populations and where ethical principles do not assume the same importance. As a result there is a reduction in the number of clinical trials performed in Europe, including Portugal. In this scope it has become imperative to make efforts to increase the attractiveness of Europe as a region for conducting clinical trials. These efforts envolves both European and national legislation improvement, in order to streamline and simplify the entire process of a clinical trial and adapt it to the today’s needs without reducing the protection of the participants. The aim of this thesis is to present and clarify the current status of clinical trials in Portugal and frame it in the European context.
The development of scientific and medical knowledge arose from clinical research, and its objective is to explore whether a medical strategy, treatment, or device is safe and effective for humans. The development of a clinical trial involves a coordination and cooperation between diferent entities, mainly the competent authority, the sponsor, the investigator and the ethics committee. It is essential to understand the role and responsibility of these entities and how they interact with each other. The entire process from strategic planning to the development of the clinical trial is legislated by well-defined rules, and primarily focused towards protecting the rights and welfare of participants and to obtain clinical data with high scientific quality. This regulatory framework was developed throughout the twentieth century, alongside the evolution of ethical framework. Despite the scientific and ethical quality provided by developed countries, in the twenty-first century we began to attend to a relocation of clinical trials to developing countries, particularly Asia, South America and Africa. These are regions that involve vulnerable populations and where ethical principles do not assume the same importance. As a result there is a reduction in the number of clinical trials performed in Europe, including Portugal. In this scope it has become imperative to make efforts to increase the attractiveness of Europe as a region for conducting clinical trials. These efforts envolves both European and national legislation improvement, in order to streamline and simplify the entire process of a clinical trial and adapt it to the today’s needs without reducing the protection of the participants. The aim of this thesis is to present and clarify the current status of clinical trials in Portugal and frame it in the European context.
Descrição
Orientação : João Martins
Palavras-chave
ÉTICA, ENSAIOS CLÍNICOS, MESTRADO EM GESTÃO DE UNIDADES DE SAÚDE, ETHICS, CLINICAL TRIALS, CIÊNCIAS FARMACÊUTICAS, PHARMACEUTICAL SCIENCES