{"id":7745,"date":"2020-06-05T11:44:07","date_gmt":"2020-06-05T11:44:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7745"},"modified":"2020-06-05T11:55:08","modified_gmt":"2020-06-05T11:55:08","slug":"the-difficulties-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/the-difficulties-in-clinical-trials\/","title":{"rendered":"As Dificuldades em Ensaios Cl\u00ednicos"},"content":{"rendered":"

Os estudos cient\u00edficos s\u00e3o projetados com uma s\u00e9rie de experimentos de controle e r\u00e9plicas, de modo que a resposta \u00e0 pergunta a ser investigada seja clara. Em conjuntos experimentais complexos como ensaios cl\u00ednicos, os resultados s\u00e3o freq\u00fcentemente menos claros, tornando imposs\u00edvel a extrapola\u00e7\u00e3o de dados [1]. De fato, relat\u00f3rios t\u00eam indicado que muitos ensaios cl\u00ednicos s\u00e3o concebidos de forma insuficiente, produzindo resultados amb\u00edguos ou in\u00fateis [1-3]. Outras quest\u00f5es, como o recrutamento de pacientes suficientes para o tamanho correto da amostragem [4], o vi\u00e9s e as percep\u00e7\u00f5es durante o recrutamento [2, 5], a retirada do paciente de um ensaio [5, 6], a falta de transpar\u00eancia ou a falta de revis\u00e3o especializada suficiente [1, 7] s\u00e3o fatores muito reais que podem confundir o estudo, tornando conclus\u00f5es claras e cortadas dif\u00edceis de se alcan\u00e7ar. Al\u00e9m disso, a valida\u00e7\u00e3o do medicamento geralmente continua ap\u00f3s aprova\u00e7\u00e3o para o mercado, em n\u00edvel populacional onde os efeitos raros, adversos ou fora do alvo s\u00f3 s\u00e3o observados com um tamanho de amostra enorme e por per\u00edodos de tempo mais longos [8].\u00a0<\/span><\/p>\n

Todo o processo de desenvolvimento de medicamentos \u00e9 demorado e \u00e1rduo porque envolve testes rigorosos de efic\u00e1cia e seguran\u00e7a em humanos. Entretanto, este processo \u00e9 necess\u00e1rio para fornecer ao p\u00fablico um perfil razoavelmente completo do novo medicamento ou de um medicamento existente usado para uma nova indica\u00e7\u00e3o. O rigor nos ensaios cl\u00ednicos tamb\u00e9m \u00e9 necess\u00e1rio para minimizar trag\u00e9dias como as do <\/span>BIA 10-2474 trial [9, 10], o <\/span>Julgamento Theralizumab [11], <\/span>o ensaio de terapia gen\u00e9tica para defici\u00eancia de transarbamilase de ornitina (OTC) [12], <\/span>e o desastre da talidomida durante as d\u00e9cadas de 1950 e 1960 [13].\u00a0<\/span><\/p>\n

Cada trag\u00e9dia tem levado a muitos esfor\u00e7os da comunidade cient\u00edfica, institui\u00e7\u00f5es m\u00e9dicas e \u00f3rg\u00e3os governamentais para aumentar a comunica\u00e7\u00e3o, consulta e reconhecimento precoce de problemas para prevenir danos e avaliar melhor a aplicabilidade de futuros ensaios [14-17]. Entretanto, o processo desde a descoberta de drogas at\u00e9 o mercado ainda est\u00e1 longe de ser perfeito. Durante os \u00faltimos meses, o mundo tem testemunhado a complexidade e muitas vezes a inconclusividade dos estudos cient\u00edficos. Com as recentes not\u00edcias de resultados positivos do ensaio Remdesivir em pacientes graves da COVID-19 e a acelera\u00e7\u00e3o da aprova\u00e7\u00e3o do medicamento pela FDA [18, 19], precisamos nos lembrar que ainda h\u00e1 mais trabalho a ser feito.\u00a0<\/span><\/p>\n

    \n
  1. Ioannidis, J.P., <\/span>Why Most Clinical Pesquisa<\/a> Is Not Useful.<\/span><\/i> PLoS Med, 2016. 13(6): p. e1002049.<\/span><\/li>\n
  2. Treweek, S. e M. Zwarenstein, <\/span>Fazer com que os ensaios sejam importantes: ensaios pragm\u00e1ticos e explicativos e o problema da aplicabilidade.<\/span><\/i> Ensaios, 2009. 10: p. 37.<\/span><\/li>\n
  3. Slattery, P., A.K. Saeri, e P. Bragge, <\/span>Co-design de pesquisa em sa\u00fade: uma r\u00e1pida vis\u00e3o geral das revis\u00f5es.<\/span><\/i> Health Res Policy Syst, 2020. 18(1): p. 17.<\/span><\/li>\n
  4. Reynolds, T.., <\/span>Ensaios cl\u00ednicos: a tecnologia pode resolver o problema do baixo recrutamento?<\/span><\/i> BMJ, 2011. 342: p. d3662.<\/span><\/li>\n
  5. Lehmann, B.A., et al, <\/span>\"E depois entrou no Grupo Errado\": Um Estudo Qualitativo Explorando os Efeitos da Randomiza\u00e7\u00e3o no Recrutamento para um Julgamento Randomizado Controlado.<\/span><\/i> Int J Environ Res Sa\u00fade P\u00fablica, 2020. 17(6).<\/span><\/li>\n
  6. Cleland , J.G.F., et al, <\/span>Um m\u00e9todo para reduzir a perda para acompanhamento - em ensaios cl\u00ednicos: informa\u00e7\u00e3o, retirada do consentimento.<\/span><\/i> European Journal of Heart Failure 2004. 6<\/span><\/li>\n<\/ol>\n

    \u00a0<\/b>(1).<\/span><\/p>\n

      \n
    1. Miyakawa, T.., <\/span>Sem dados brutos, sem ci\u00eancia: outra poss\u00edvel fonte da crise de reprodutibilidade.<\/span><\/i> Mol Brain, 2020. <\/span>13<\/b>(1): p. 24.<\/span><\/li>\n
    2. Raj, N., et al, <\/span>Vigil\u00e2ncia p\u00f3s-mercado: uma revis\u00e3o sobre aspectos-chave e medidas sobre o funcionamento eficaz no contexto do Reino Unido e do Canad\u00e1.<\/span><\/i> Ther Adv Adv Drug Saf, 2019. <\/span>10<\/b>: p. 2042098619865413.<\/span><\/li>\n
    3. Randerson, J., <\/span>O ensaio cl\u00ednico franc\u00eas fatal falhou em verificar os dados antes de elevar a dose do medicamento.<\/span><\/i> Nature News, 2016.<\/span><\/li>\n
    4. Kaur, R., P. Sidhu, e S. Singh, <\/span>O que falhou no ensaio cl\u00ednico BIA 10-2474 Fase I? Especula\u00e7\u00f5es globais e recomenda\u00e7\u00f5es para futuros ensaios da Fase I.<\/span><\/i> J Pharmacol Pharmacother, 2016. <\/span>7<\/b>(3): p. 120-6.<\/span><\/li>\n
    5. Attarwala, H., <\/span>TGN1412: Da Descoberta ao Desastre.<\/span><\/i> J Young Pharm, 2010. <\/span>2<\/b>(3): p. 332-6.<\/span><\/li>\n
    6. Rinde, M.., <\/span>A Morte de Jesse Gelsinger, 20 Anos Depois<\/span><\/i>, em <\/span>Instituto de Hist\u00f3ria da Ci\u00eancia - Destila\u00e7\u00f5es<\/span><\/i>. 2019.<\/span><\/li>\n
    7. Vargesson, N., <\/span>Teratog\u00eanese induzida por talidomida: hist\u00f3ria e mecanismos.<\/span><\/i> Defeitos de Nascimento Res C Embri\u00e3o Hoje, 2015. <\/span>105<\/b>(2): p. 140-56.<\/span><\/li>\n
    8. Lipman, P.D., L. Dluzak, e C.M. Stoney, <\/span>Este estudo \u00e9 vi\u00e1vel? Facilitando a gest\u00e3o de marcos de planejamento pragm\u00e1tico de testes sob um mecanismo de financiamento por fases.<\/span><\/i> Trials, 2019. <\/span>20<\/b>(1): p. 307.<\/span><\/li>\n
    9. Dal-R\u00e9, R., P. Janiaud, e J.P.A. Ioannidis, <\/span>Evid\u00eancia do mundo real: Qu\u00e3o pragm\u00e1ticos s\u00e3o os ensaios controlados aleat\u00f3rios rotulados como pragm\u00e1ticos?<\/span><\/i> BMC Med, 2018. <\/span>16<\/b>(1): p. 49.<\/span><\/li>\n
    10. Reijers, J.A.A., et al, <\/span>Imuno-estimula\u00e7\u00e3o adversa causada por impurezas: O lado escuro dos biofarmac\u00eauticos.<\/span><\/i> Br J Clin Pharmacol, 2019. <\/span>85<\/b>(7): p. 1418-1426.<\/span><\/li>\n
    11. Van Norman, G.A, <\/span>Limita\u00e7\u00f5es dos Estudos em Animais para Previs\u00e3o da Toxicidade em Ensaios Cl\u00ednicos: \u00c9 hora de repensar nossa abordagem atual?<\/span><\/i> JACC Basic Transl Sci, 2019. <\/span>4<\/b>(7): p. 845-854.<\/span><\/li>\n
    12. Doen\u00e7as, N.I.o.A.a.I., <\/span>NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19<\/span><\/i>N.I.o. Health, Editor. 2020.<\/span><\/li>\n
    13. Gilead, <\/span>Gilead anuncia os resultados da Fase 3 do Teste de Investiga\u00e7\u00e3o de Remanescentes Antivirais em Pacientes com COVID-19 Severa<\/span><\/i>, Gilead, Editor. 2020.<\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"

      Scientific studies are designed with a number of control experiments and replications such that the answer to the question being investigated is clear. In complex experimental set-ups like clinical trials, results are often less clear making extrapolation of data impossible [1]. In fact, reports have indicated that many clinical trials are insufficiently designed, yielding ambiguous<\/p>\n

      Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":7750,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[435],"tags":[],"acf":[],"yoast_head":"\nThe Difficulties in Clinical Trials - The Kolabtree Blog<\/title>\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-difficulties-in-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Difficulties in Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Scientific studies are designed with a number of control experiments and replications such that the answer to the question being investigated is clear. 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