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Authors
Advisor(s)
Abstract(s)
Objetivo - Os Ensaios Clínicos podem ser considerados uma tecnologia de saúde que permite desenvolver o conhecimento científico e o acesso a novas tecnologias. Sendo que a publicação nesta área é limitada; esta investigação pretende verificar a distribuição dos Ensaios Clínicos pelos países da União Europeia, e também a possível influência de variáveis ecológicas nessa distribuição. Pretende-se ainda focalizar a análise nos Ensaios Clínicos realizados na área da Diabetes, considerando a sua prevalência estimada de 13,1% em Portugal, o que, de acordo com alguns autores, poderá ser relevante na escolha do país para a realização de Ensaios Clínicos. Metodologia - Esta investigação é classificada como um estudo ecológico, utilizando bases de dados de acesso aberto, que permitam replicar a metodologia em futuros estudos. A análise das variáveis foi auxiliada com recurso a interpretação crítica de gráficos e tabelas, auxiliada pela aplicação de coeficientes de correlação. Resultados - Ao longo dos últimos 10 anos foram realizados 36.968 Ensaios Clínicos na União Europeia. Verifica-se que os países de maior dimensão, com maior PIB e com maior número de doentes diabéticos estimados apresentam maior valor médio de Ensaios Clínicos. Foi possível observar diferenças de performance nos países de média dimensão. Este facto levou à realização de sub-análises, nomeadamente para os países nórdicos e para países de Leste. Conclusão - Apesar de não ser possível identificar as verdadeiras razões que limitam a participação de alguns países da União Europeia em Ensaios Clínicos, com a presente investigação pode-se afirmar que ainda existe um longo percurso a percorrer no desenvolvimento de estratégias que tornem a participação de todos os países equilibrada e alinhada com o seu real potencial.
ABSTRACT - Objective: Clinical Trials can be considered a health technology, which allows the development of scientific knowledge and the access to new technologies. Research in this area is limited; this paper aims to verify the distribution of Clinical Trials within the European Union, and also the potential influence of ecologic variables in this distribution. It is also an objective to focus on the Diabetes’ Clinical Trials, considering its estimated prevalence of 13,1% in Portugal, which according to some authors, could be relevant in the choice of countries participating in Clinical Trials. Methodology: This research is categorized as an ecological study, using open-access databases, which allow methodology-replication in future studies. The analysis of the variables was conducted through the interpretation of charts and tables, supported by the use of correlation coefficients. Results: Through the last 10 years, 36.968 Clinical Trials were performed in the European Union. It was verified that the countries of larger dimension, with higher GDP, and with higher estimated diabetic patients present a higher average of Clinical Trials. It was possible to note differences in the performance of countries with average dimension. This finding led to the sub-analysis focused on Nordic and Eastern countries. Conclusion: Although it was not possible to identify the real reasons that restrict the participation of some European Union countries in Clinical Trials, with the present research it is possible to state that there is still a long journey ahead in the development of strategies which will allow a balanced participation of each country, in line with their true-potential.
ABSTRACT - Objective: Clinical Trials can be considered a health technology, which allows the development of scientific knowledge and the access to new technologies. Research in this area is limited; this paper aims to verify the distribution of Clinical Trials within the European Union, and also the potential influence of ecologic variables in this distribution. It is also an objective to focus on the Diabetes’ Clinical Trials, considering its estimated prevalence of 13,1% in Portugal, which according to some authors, could be relevant in the choice of countries participating in Clinical Trials. Methodology: This research is categorized as an ecological study, using open-access databases, which allow methodology-replication in future studies. The analysis of the variables was conducted through the interpretation of charts and tables, supported by the use of correlation coefficients. Results: Through the last 10 years, 36.968 Clinical Trials were performed in the European Union. It was verified that the countries of larger dimension, with higher GDP, and with higher estimated diabetic patients present a higher average of Clinical Trials. It was possible to note differences in the performance of countries with average dimension. This finding led to the sub-analysis focused on Nordic and Eastern countries. Conclusion: Although it was not possible to identify the real reasons that restrict the participation of some European Union countries in Clinical Trials, with the present research it is possible to state that there is still a long journey ahead in the development of strategies which will allow a balanced participation of each country, in line with their true-potential.
Description
Mestrado em Gestão e Avaliação de Tecnologias em Saúde
Keywords
Ensaio clínico Tecnologias da saúde Clinical trial Health technology União Europeia European Union
Citation
Couceiro JP. Mercado europeu de ensaios clínicos: de 2006 a 2015 (população, PIB, %PIB gasto em saúde e diabetes como fatores diferenciadores) [Dissertation]. Lisboa: Escola Superior de Tecnologia da Saúde de Lisboa/Instituto Politécnico de Lisboa; 2017.
Publisher
Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa