Desafios da pesquisa clínica com população pediátrica no Brasil
Data
2024-08-19
Autores
Campos, Marina Rosseto de Almeida 
Orientadores
Nappo, Solange Aparecida
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O objetivo deste trabalho de conclusão de curso foi analisar as particularidades dos ensaios clínicos na população pediátrica, tanto no Brasil quanto no mundo, e destacar as dificuldades e a importância de conduzir estudos clínicos nessa faixa etária. Para isso, foi realizada uma revisão de artigos científicos internacionais e/ou nacionais, disponíveis nas bases de dados Scielo, PubMed e Google Acadêmico, além de materiais publicados em sites relevantes das agências ético-regulatórias.
Em seguida, foram coletadas informações sobre a pesquisa clínica no desenvolvimento de novos medicamentos nessas mesmas bases de dados, bem como as principais regulamentações aplicáveis ao tema. Dessa forma, foi possível analisar o perfil dos estudos clínicos em crianças e adolescentes, comparando-os com os estudos realizados em adultos, tanto no Brasil e América Latina quanto nos Estados Unidos e Europa. Com o intuito de compreender as diferenças de resultados entre essas regiões, também foi realizada uma análise exploratória nos sites das agências reguladoras de cada local, uma vez que as iniciativas regulatórias podem influenciar a quantidade de ensaios clínicos pediátricos realizados.
Por fim, foi realizada uma revisão bibliográfica no PubMed para examinar os principais obstáculos enfrentados e propor melhorias na condução dos ensaios clínicos em crianças e adolescentes. Como resultado, observou-se que a quantidade de ensaios clínicos pediátricos no Brasil e na América Latina é inferior à dos Estados Unidos e Europa. Foi possível constatar que as regulamentações dessas regiões tiveram um impacto significativo no crescimento dos ensaios clínicos pediátricos, enquanto o Brasil e países como México e Argentina ainda não possuem uma legislação específica para estudos em crianças, o que dificulta o avanço dessa área de pesquisa.
Considerando que questões financeiras e ético-regulatórias são os maiores desafios na condução dos ensaios clínicos pediátricos, sugere-se a criação de iniciativas regulatórias e a simplificação dos trâmites ético-regulatórios como forma de incentivar o crescimento desses estudos.
The objective of this undergraduate thesis was to analyze the peculiarities of clinical trials in the pediatric population, both in Brazil and worldwide, and highlight the difficulties and importance of conducting clinical studies in this age group. For this purpose, a review of international and/or national scientific articles available in the Scielo, PubMed, and Google Scholar databases was conducted, along with materials published on relevant websites of ethical-regulatory agencies. Subsequently, information on clinical research in the development of new drugs in these same databases was collected, as well as the main regulations applicable to the subject. This allowed for the analysis of the profile of clinical studies in children and teenagers, comparing them with studies conducted in adults, both in Brazil and Latin America, as well as in the United States and Europe. In order to understand the differences in results between these regions, an exploratory analysis was also conducted on the websites of the regulatory agencies in each location, as regulatory initiatives can influence the number of pediatric clinical trials conducted. Finally, a literature review was conducted on PubMed to examine the main obstacles faced and propose improvements in the conduct of clinical trials in children and teenagers. As a result, it was observed that the number of pediatric clinical trials in Brazil and Latin America is lower than that in the United States and Europe. It was found that the regulations in these regions had a significant impact on the growth of pediatric clinical trials, while Brazil and countries like Mexico and Argentina still do not have specific legislation for studies in children, which hinders the advancement of this research area. Considering that financial and ethical-regulatory issues are the major challenges in conducting pediatric clinical trials, it is suggested to create regulatory initiatives and simplify ethical-regulatory procedures as a way to encourage the growth of these studies.
The objective of this undergraduate thesis was to analyze the peculiarities of clinical trials in the pediatric population, both in Brazil and worldwide, and highlight the difficulties and importance of conducting clinical studies in this age group. For this purpose, a review of international and/or national scientific articles available in the Scielo, PubMed, and Google Scholar databases was conducted, along with materials published on relevant websites of ethical-regulatory agencies. Subsequently, information on clinical research in the development of new drugs in these same databases was collected, as well as the main regulations applicable to the subject. This allowed for the analysis of the profile of clinical studies in children and teenagers, comparing them with studies conducted in adults, both in Brazil and Latin America, as well as in the United States and Europe. In order to understand the differences in results between these regions, an exploratory analysis was also conducted on the websites of the regulatory agencies in each location, as regulatory initiatives can influence the number of pediatric clinical trials conducted. Finally, a literature review was conducted on PubMed to examine the main obstacles faced and propose improvements in the conduct of clinical trials in children and teenagers. As a result, it was observed that the number of pediatric clinical trials in Brazil and Latin America is lower than that in the United States and Europe. It was found that the regulations in these regions had a significant impact on the growth of pediatric clinical trials, while Brazil and countries like Mexico and Argentina still do not have specific legislation for studies in children, which hinders the advancement of this research area. Considering that financial and ethical-regulatory issues are the major challenges in conducting pediatric clinical trials, it is suggested to create regulatory initiatives and simplify ethical-regulatory procedures as a way to encourage the growth of these studies.