Monitoria de dados em estudos clínicos: mudanças durante a pandemia de COVID-19 e perspectivas para o futuro uma revisão de escopo
Data
2023-06-15
Autores
Ribeiro, Isabela Arantes 
Orientadores
Castelo, Paula Midori
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Esta revisão de escopo visa discutir os desafios à monitoria de dados durante a pandemia de COVID-19, as novas tecnologias, limitações éticas e regulatórias, o impacto para os participantes de pesquisa e as tendências para a monitoria baseada em risco de estudos multicêntricos e patrocinados. As buscas e extração de dados foram realizadas entre fevereiro e maio de 2023 nas bases de dados PubMed e Embase por duas pesquisadoras. As palavras-chave utilizadas foram “clinical trials”, “clinical research” e “risk based monitoring”, sem restrição de data, desenho do estudo ou língua. Repositórios e sites de organizações específicos foram consultados (ANVISA, CONEP, Conselho Internacional para Harmonização de Requisitos Técnicos para Produtos Farmacêuticos de Uso Humano, Food and Drug Administration e Agência Europeia de Medicamentos). Dos 149 artigos encontrados, 110 foram excluídos por serem duplicados ou fora do escopo e 39 estudos foram submetidos à apreciação; somados a estes, 10 documentos e notas técnicas de organizações regulatórias do tema foram revisados. Até 2020, a verificação de 100% dos dados ocorria majoritariamente de forma presencial nos centros de pesquisa e a pandemia da COVID-19 impulsionou o uso de metodologias remotas de monitoramento. A ANVISA autorizou a utilização de métodos alternativos buscando a proteção dos participantes, como o contato telefônico, a visita virtual e a telemedicina, mediante aprovação do sistema CEP/CONEP e observância da LGPD. Orientações durante a pandemia também foram publicadas pelo European Medicines Agency e Food and Drug Administration para a realização de atividades de monitoramento fora dos Centros de Pesquisas. Dados da literatura mostraram que estudos com monitoramento tradicional perfaziam 47% em 2019, 23% em 2020 e 12% em 2021. Apesar da tendência de aumento do uso de monitoramento remoto, não há diretrizes claras e específicas sobre quando esta é a melhor opção e orientações específicas dos melhores métodos e recursos, mostrando que as abordagens apresentadas neste estudo ainda carecem de padronização de processos e critérios.
This scoping review aims to discuss challenges to data monitoring during the COVID- 19 pandemic, new technologies, ethical and regulatory limitations, impact on research participants, and trends towards risk-based monitoring of multicenter, sponsored and decentralized studies. Data searches and extraction were carried out between February and May 2023 in the PubMed and Embase databases by two researchers. The keywords used were “clinical trials”, “clinical research” and “risk-based monitoring”, with no restriction on date, study design or language. Repositories and websites of specific organizations were consulted (ANVISA, CONEP, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Food and Drug Administration and European Medicines Agency). Of the 149 articles found, 110 were excluded for being duplicated or out of scope and 39 studies were submitted for appreciation; in addition to these, 10 documents and technical notes from regulatory organizations on the subject were reviewed. Until 2020, verification of 100% of the data mostly occurred in person at research centers and the COVID-19 pandemic increased the use of remote monitoring methodologies. ANVISA authorized the use of alternative methods with the aim of protecting the participants, such as telephone contact, virtual visits and telemedicine, upon approval by the CEP/CONEP system and compliance with the LGPD. Guidance during the pandemic has also been published by the European Medicines Agency and Food and Drug Administration for carrying out monitoring activities outside of Research Centers. Data from the literature showed that studies with traditional monitoring accounted for 47% in 2019, 23% in 2020 and 12% in 2021. Despite the trend towards increased use of remote monitoring, there are no clear and specific guidelines on when this is the best option and specific guidelines for the best methods and resources, showing that the approaches presented in this study still lack standardization of processes and criteria.
This scoping review aims to discuss challenges to data monitoring during the COVID- 19 pandemic, new technologies, ethical and regulatory limitations, impact on research participants, and trends towards risk-based monitoring of multicenter, sponsored and decentralized studies. Data searches and extraction were carried out between February and May 2023 in the PubMed and Embase databases by two researchers. The keywords used were “clinical trials”, “clinical research” and “risk-based monitoring”, with no restriction on date, study design or language. Repositories and websites of specific organizations were consulted (ANVISA, CONEP, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Food and Drug Administration and European Medicines Agency). Of the 149 articles found, 110 were excluded for being duplicated or out of scope and 39 studies were submitted for appreciation; in addition to these, 10 documents and technical notes from regulatory organizations on the subject were reviewed. Until 2020, verification of 100% of the data mostly occurred in person at research centers and the COVID-19 pandemic increased the use of remote monitoring methodologies. ANVISA authorized the use of alternative methods with the aim of protecting the participants, such as telephone contact, virtual visits and telemedicine, upon approval by the CEP/CONEP system and compliance with the LGPD. Guidance during the pandemic has also been published by the European Medicines Agency and Food and Drug Administration for carrying out monitoring activities outside of Research Centers. Data from the literature showed that studies with traditional monitoring accounted for 47% in 2019, 23% in 2020 and 12% in 2021. Despite the trend towards increased use of remote monitoring, there are no clear and specific guidelines on when this is the best option and specific guidelines for the best methods and resources, showing that the approaches presented in this study still lack standardization of processes and criteria.