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A investigação clínica em Portugal: do pós-guerra aos dias de hoje
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A investigação clínica está presente desde os primórdios da humanidade onde os
nossos antecessores procuravam descobrir plantas ou outras formas que curassem os seus
males. No entanto, a investigação atualmente não se processa da mesma forma que se
processava inicialmente.
Esta não é uma área estanque e encontra-se em constante evolução, sofrendo
alterações significativas após a segunda guerra mundial e o conhecimento das experiências
desumanas levadas a cabo pelos Nazis. Passaram a existir normas éticas, código de
Nuremberga, para guiar a experimentação em seres humanos, bem como outras normas
publicadas posteriormente seguindo os mesmos ideais.
No entanto, estas verificaram-se insuficientes quando se revelou a ocorrência de
casos como o caso do Jewish Chronic Disease Hospital, estudo em Willowbrook ou o
estudo de Tuskegee. Para evitar que se continuasse a verificar casos semelhantes, houve
novas alterações nas normas éticas e iniciou-se a regulamentação mais forte da
investigação clínica, passando a existir autoridades regulamentares de cada país (FDA,
INFARMED, etc) bem como a nível europeu (EMA) e mundial (ICH) para se certificar do
cumprimento das normas éticas e regulamentares.
Com o evoluir da investigação clínica também se verificou a distinção entre estudos
com menor necessidade de regulamentação e estudos que, acarretando um maior perigo
para a integridade física dos participantes requeriam, portanto, uma regulamentação mais
exigente – ensaios clínicos.
Atualmente existem diversos desafios nesta área, não só em Portugal como no
mundo. Em Portugal é necessário aumentar o número de estudos quer a nível académico
quer a nível da indústria, para tal o governo tomou medidas como a criação dos centros
clínicos académicos e o projeto pilotos dos hospitais universitários. A nível mundial,
atualmente encontramos o dilema ético do uso do placebo como controlo bem como a
emergência dos estudos usando Big Data, tendo em conta o seu potencial e as suas
limitações. Estes são alguns dos desafios atuais, aos quais as autoridades regulamentares
têm de dar resposta, bem como os investigadores, de modo a que a investigação clínica
possa evoluir preservando sempre a integridade física e psíquica dos participantes
envolvidos.
Clinical research is present since the beginning of mankind, when our predecessors would search for plants or other sources that would heal their wounds. However, nowadays the research does not occur in the same context or way that did initially. This is an area in constant evolution and therefore suffering constant modifications. The most significant one, might be considered the aftermath of the World War II and the inhumane experiences conducted by the Nazis during this period. After this period ethical norms were created, like the Nuremberg Code, as well as other guidelines published afterwards following the same ideology, to serve as guide for human experimentation. Nonetheless, they revealed to be insufficient because some unethical studies continued to be performed like the case in The Jewish Chronic Disease Hospital, the study at Willowbrook and the Tuskegee study. In order not to let the history repeat itself, some changes were made in the ethical norms and were also published more strict regulations and legislations regarding studies conducted on human beings. Furthermore, regulatory authorities were created so that they could be responsible for the enforcement of the laws regarding the studies conducted in humans. (FDA, INFARMED, EMA, ICH). As clinical studies evolved, there were some differences in them and therefore the need to differentiate the regulations and norms for each type, the observational studies meant less harm and risk and therefore did not need as much regulation as the clinical trials that could imply bigger risk for the participants. Currently, there are many challenges in this area, not only in Portugal but worldwide. In Portugal, there is a need to increase the number of studies, both academic ones and industry ones. To do so, the government created clinical academic centers and implemented a pilot project – university hospitals. Worldwide, nowadays there is an ethical dilemma related to the use of placebos as controls as well as the emerging studies using Big Data and their potential and limitations. These are some of the current challenges that legal authorities and investigators need to tackle in order to have progress in the area of clinical research but always respecting the physical and psychic integrity of the participants involved.
Clinical research is present since the beginning of mankind, when our predecessors would search for plants or other sources that would heal their wounds. However, nowadays the research does not occur in the same context or way that did initially. This is an area in constant evolution and therefore suffering constant modifications. The most significant one, might be considered the aftermath of the World War II and the inhumane experiences conducted by the Nazis during this period. After this period ethical norms were created, like the Nuremberg Code, as well as other guidelines published afterwards following the same ideology, to serve as guide for human experimentation. Nonetheless, they revealed to be insufficient because some unethical studies continued to be performed like the case in The Jewish Chronic Disease Hospital, the study at Willowbrook and the Tuskegee study. In order not to let the history repeat itself, some changes were made in the ethical norms and were also published more strict regulations and legislations regarding studies conducted on human beings. Furthermore, regulatory authorities were created so that they could be responsible for the enforcement of the laws regarding the studies conducted in humans. (FDA, INFARMED, EMA, ICH). As clinical studies evolved, there were some differences in them and therefore the need to differentiate the regulations and norms for each type, the observational studies meant less harm and risk and therefore did not need as much regulation as the clinical trials that could imply bigger risk for the participants. Currently, there are many challenges in this area, not only in Portugal but worldwide. In Portugal, there is a need to increase the number of studies, both academic ones and industry ones. To do so, the government created clinical academic centers and implemented a pilot project – university hospitals. Worldwide, nowadays there is an ethical dilemma related to the use of placebos as controls as well as the emerging studies using Big Data and their potential and limitations. These are some of the current challenges that legal authorities and investigators need to tackle in order to have progress in the area of clinical research but always respecting the physical and psychic integrity of the participants involved.
Descrição
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Investigação clínica Ensaios clínicos História Ética Big Data Teses de mestrado - 2021