{"id":8151,"date":"2020-07-30T09:21:34","date_gmt":"2020-07-30T09:21:34","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8151"},"modified":"2020-07-30T09:30:15","modified_gmt":"2020-07-30T09:30:15","slug":"the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/","title":{"rendered":"O impacto da COVID-19 nos ensaios cl\u00ednicos: desafios e oportunidades"},"content":{"rendered":"

Neste artigo\u00a0escritor m\u00e9dico freelance<\/a>\u00a0para Kolabtree\u00a0Laura Moro-Martin<\/a>MSc, PhD, discute o impacto da COVID-19 nos ensaios cl\u00ednicos.\u00a0<\/i><\/b><\/span><\/p>\n

A pandemia de Coronavirus 2019 (COVID-19) est\u00e1 sem d\u00favida tendo um efeito perturbador sobre os sistemas de sa\u00fade e a presta\u00e7\u00e3o de cuidados de sa\u00fade em todo o mundo. Prev\u00ea-se que a sobrecarga dos sistemas de sa\u00fade em muitos pa\u00edses causar\u00e1 um aumento preocupante tanto na mortalidade direta da COVID-19 quanto na mortalidade indireta de outras condi\u00e7\u00f5es [1,2]. Por exemplo, as visitas de emerg\u00eancia foram substancialmente reduzidas [3] e v\u00e1rias campanhas de vacina\u00e7\u00e3o foram interrompidas devido ao surgimento da COVID-19 [4], o que pode contribuir para a morbidade e mortalidade indireta.<\/p>\n

Pr\u00e1tica da pesquisa cl\u00ednica<\/a> n\u00e3o \u00e9 exce\u00e7\u00e3o, com a pandemia causando tremendas interrup\u00e7\u00f5es nos ensaios cl\u00ednicos em andamento. Isto \u00e9 particularmente relevante para ensaios que n\u00e3o lidam diretamente com a preven\u00e7\u00e3o ou tratamento da COVID-19, e aqueles que requerem o acesso dos participantes aos locais cl\u00ednicos. Um estudo espanhol sobre ensaios em fase inicial de c\u00e2ncer pedi\u00e1trico relatou escassez de pessoal, dificuldades na inscri\u00e7\u00e3o de pacientes (at\u00e9 75% de redu\u00e7\u00e3o da inscri\u00e7\u00e3o esperada e 50% de ensaios em andamento interrompendo o recrutamento), problemas para a continuidade do tratamento e atrasos nas avalia\u00e7\u00f5es dos ensaios (com atividades de monitoramento adiadas em 73% de casos) [5]. Uma pesquisa da Sociedade Americana de Oncologia Cl\u00ednica sobre 32 programas de c\u00e2ncer em ensaios cl\u00ednicos identificou numerosos desafios, incluindo dificuldades na inscri\u00e7\u00e3o (60% dos respondentes declarou a suspens\u00e3o da inscri\u00e7\u00e3o e\/ou triagem) e ades\u00e3o ao protocolo, diminui\u00e7\u00e3o das visitas aos pacientes (60% dos respondentes), limita\u00e7\u00f5es de pessoal, e estreita disponibilidade de servi\u00e7os auxiliares (50% dos respondentes) [6]. Para pacientes com c\u00e2ncer ou outras condi\u00e7\u00f5es graves, a participa\u00e7\u00e3o em um ensaio cl\u00ednico poderia ser uma parte essencial do tratamento que n\u00e3o pode ser interrompida.\u00a0<\/span><\/p>\n

Outros desafios relatados como conseq\u00fc\u00eancia da pandemia incluem intera\u00e7\u00f5es com patrocinadores e CROs sobre a modifica\u00e7\u00e3o dos procedimentos de ensaio, e modifica\u00e7\u00f5es e\/ou desvios de protocolo - intencionais ou n\u00e3o - com efeitos desconhecidos sobre a integridade cient\u00edfica, interpreta\u00e7\u00e3o e conclus\u00f5es dos ensaios [6]. Alguns autores alertaram sobre a possibilidade de que mudan\u00e7as for\u00e7adas introduzidas em ensaios cl\u00ednicos pela pandemia - como a diminui\u00e7\u00e3o das visitas de acompanhamento, a sa\u00fade mental ou f\u00edsica mais prec\u00e1ria dos participantes, ou mesmo a infec\u00e7\u00e3o com o novo coronav\u00edrus - possam interferir nos resultados dos riscos e benef\u00edcios do tratamento [7]. Al\u00e9m disso, o impacto da COVID-19 nos ensaios cl\u00ednicos \u00e9 desigual, dependendo da \u00e1rea terap\u00eautica. Um relat\u00f3rio encontrou diminui\u00e7\u00f5es na inscri\u00e7\u00e3o de participantes variando de 34% para doen\u00e7as respirat\u00f3rias at\u00e9 80% para doen\u00e7as end\u00f3crinas, com percentuais intermedi\u00e1rios para outras \u00e1reas terap\u00eauticas (47% para doen\u00e7as infecciosas, 48% para oncologia, 64% para dermatologia, 68% para doen\u00e7as neurol\u00f3gicas, e 70% para doen\u00e7as cardiovasculares) [8].<\/span><\/p>\n

A US Food and Drug Administration (FDA) [9] emitiu orienta\u00e7\u00f5es para que a ind\u00fastria, os investigadores e os conselhos de revis\u00e3o institucional realizem ensaios cl\u00ednicos de produtos m\u00e9dicos durante a crise da COVID-19, garantindo ao mesmo tempo a prote\u00e7\u00e3o dos pacientes e dos profissionais de sa\u00fade. Da mesma forma, a Ag\u00eancia Europ\u00e9ia de Medicamentos (EMA) publicou orienta\u00e7\u00f5es para os patrocinadores sobre como administrar os ensaios cl\u00ednicos durante a pandemia [10]. Esta orienta\u00e7\u00e3o ap\u00f3ia certa flexibilidade de protocolo em rela\u00e7\u00e3o \u00e0 pol\u00edtica e procedimentos para garantir a integridade da pesquisa cl\u00ednica, incluindo mudan\u00e7as nas visitas e procedimentos de estudo, coleta de dados, monitoramento de estudos, relato de eventos adversos ou mudan\u00e7as nos investigadores, pessoal do local e\/ou monitores devido \u00e0 doen\u00e7a COVID-19, restri\u00e7\u00f5es de viagem ou medidas de quarentena [11]. Ag\u00eancias m\u00e9dicas em diferentes pa\u00edses adotaram uma variedade de medidas para garantir a seguran\u00e7a e o bem-estar dos participantes do estudo durante a pandemia, e foi publicado um guia para ajudar os patrocinadores a gerenciar os estudos cl\u00ednicos resumindo v\u00e1rias medidas nacionais [12].\u00a0<\/span><\/p>\n

Once the main obstacles have been identified \u2212mostly mobility and travel restrictions, lack of adequate technologies and disruptions in supply chains [8]\u2212 COVID-19 may be seen as an opportunity to ‘rethink’ clinical trials. Some of the solutions proposed to overcome these challenges [13,14] include moving clinical sites to countries and regions less impacted by COVID-19, virtualization of several aspects of the trial (such as remote consent, remote randomization, and remote data capture and reporting), use of technology to closely monitor patient volume and drug supply to minimize disruptions, creation of synthetic control arms from historical trial data combined with intelig\u00eancia artificial<\/a> algorithms, or offering in-home clinical services. In particular, technology innovation can provide new tools to guarantee the continuity and success of clinical studies during the pandemics. An example of this innovation is a risk-based predictive analytical approach powered by machine learning that can offer predictions and forecasts to support decision-making during clinical operations management [15].<\/span><\/p>\n

\u00c9 evidente que o efeito perturbador da COVID-19 mudou a maneira de conduzir os ensaios cl\u00ednicos, empurrando para a digitaliza\u00e7\u00e3o da sa\u00fade e o uso de ferramentas e metodologias inovadoras. Vamos aproveitar esta interrup\u00e7\u00e3o para melhorar a experi\u00eancia dos pacientes e trazer terapias seguras, eficazes e acess\u00edveis para o mercado.<\/span><\/p>\n

Bibliografia<\/b><\/p>\n

    \n
  1. Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, et al. (2020) Estimativas iniciais dos efeitos indiretos da pandemia COVID-19 sobre a mortalidade materna e infantil em pa\u00edses de baixa e m\u00e9dia renda: um estudo de modelagem. Lancet Glob Heal. doi:10.1016\/S2214-109X(20)30229-1.<\/span><\/li>\n
  2. Hogan AB, Jewell B, Sherrard-Smith E, Vesga J, Watson OJ, et al. (2020) Relat\u00f3rio 19: O impacto potencial da epidemia de COVID-19 sobre HIV, TB e mal\u00e1ria em pa\u00edses de baixa e m\u00e9dia renda. Imperial College of London.<\/span><\/li>\n
  3. Lazzerini M, Barbi E, Apicella A, Marchetti F, Cardinale F, et al. (2020) Atraso no acesso ou presta\u00e7\u00e3o de cuidados na It\u00e1lia resultante do medo da COVID-19. Lancet Child Adolesc Adolescente Heal 4: e10-e11. doi:10.1016\/S2352-4642(20)30108-5.<\/span><\/li>\n
  4. Organiza\u00e7\u00e3o Mundial da Sa\u00fade (2020) Pelo menos 80 milh\u00f5es de crian\u00e7as sob um risco de doen\u00e7as como difteria, sarampo e poliomielite, pois a COVID-19 perturba os esfor\u00e7os de vacina\u00e7\u00e3o de rotina, alertam Gavi, OMS e UNICEF. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  5. Rubio-San-Simon A, Verd\u00fa-Amor\u00f3s J, Hladun R, Ribelles AJ, Molero M, Guerra-Garc\u00eda P, P\u00e9rez-Mart\u00ednez A, Casta\u00f1eda A, Ca\u00f1ete A, Rojas Td, Moreno L BF (2020) Desafios na Fase Inicial de Ensaios Cl\u00ednicos para o C\u00e2ncer Infantil durante a Pandemia da COVID-19: Um Relat\u00f3rio do Grupo de Novos Agentes da Sociedade Espanhola de Hematologia e Oncologia Pedi\u00e1trica (SEHOP). Clin Transl Oncol: 1\u20137. doi:10.1007\/S12094-020-02399-3.<\/span><\/li>\n
  6. Waterhouse DM, Harvey RD, Hurley P, Levit LA, Kim ES, et al. (2020) Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Conclus\u00f5es de uma Pesquisa da Sociedade Americana de Oncologia Cl\u00ednica. https:\/\/doi.org\/101200\/OP2000275. doi:10.1200\/OP.20.00275.<\/span><\/li>\n
  7. Servick K (2020) Os ensaios cl\u00ednicos prosseguem para outras condi\u00e7\u00f5es al\u00e9m da COVID-19. Ser\u00e1 que os efeitos da pandemia entrar\u00e3o furtivamente em seus dados? Ci\u00eancia. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  8. Medidata (2020) COVID-19 e Ensaios Cl\u00ednicos: A Perspectiva Medidata. Vers\u00e3o 5.0. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  9. US Food and Drug Administration (2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  10. Ag\u00eancia Europ\u00e9ia de Medicamentos (2020) Orienta\u00e7\u00e3o sobre o gerenciamento de ensaios cl\u00ednicos durante a pandemia de COVID-19 (coronav\u00edrus). Dispon\u00edvel em aqui<\/a>. Acesso em 2 de junho de 2020.<\/span><\/li>\n
  11. Sarah Morgan, Liz O'Neil, Karin Parks (2020) Impacto da COVID-19 nos ensaios cl\u00ednicos. Dispon\u00edvel em aqui<\/a>. Acesso em 2 de junho de 2020.<\/span><\/li>\n
  12. DLA Piper (2020) Um guia para gerenciar os ensaios cl\u00ednicos durante a pandemia COVID-19. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  13. Fareed Melhem (2020) The Global Impact of COVID-19 on Clinical Trials and the Way Forward | Technology Networks. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  14. ICON plc (2020) Minimizar o impacto da COVID-19 nos ensaios cl\u00ednicos com servi\u00e7os cl\u00ednicos em casa. Dispon\u00edvel em aqui<\/a>. Acesso em 5 de junho de 2020.<\/span><\/li>\n
  15. Ben van der Schaaf, Thomas Unger, Michael Eiden, Ben Enejo, Craig Wylie, Tom Teixeira RE (2020) Gerenciando ensaios cl\u00ednicos durante a COVID-19 e mais al\u00e9m. Dispon\u00edvel em aqui<\/a>. Acesso em 2 de junho de 2020.<\/span><\/li>\n<\/ol>\n

     <\/p>","protected":false},"excerpt":{"rendered":"

    In this article\u00a0freelance medical writer\u00a0for Kolabtree\u00a0Laura Moro-Martin, MSc, PhD, discusses the impact of COVID-19 on clinical trials.\u00a0 Coronavirus disease 2019 (COVID-19) pandemic is undoubtedly having a disruptive effect on health systems and healthcare delivery worldwide. The overwhelm of health systems in many countries is predicted to cause a concerning increase in both direct mortality from<\/p>\n

    Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":8155,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,435],"tags":[],"acf":[],"yoast_head":"\nThe impact of COVID-19 on clinical trials: challenges and opportunities<\/title>\n<meta name=\"description\" content=\"COVID-19 has shifted the way we conduct clinical trials, pushing towards the digitalization of healthcare and the use of innovative tools and methodologies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The impact of COVID-19 on clinical trials: challenges and 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