{"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\/es\/las-dificultades-en-los-ensayos-clinicos\/","title":{"rendered":"Las dificultades de los ensayos cl\u00ednicos"},"content":{"rendered":"

Los estudios cient\u00edficos se dise\u00f1an con una serie de experimentos de control y r\u00e9plicas de manera que la respuesta a la pregunta investigada sea clara. En los montajes experimentales complejos, como los ensayos cl\u00ednicos, los resultados suelen ser menos claros, lo que hace imposible la extrapolaci\u00f3n de los datos [1]. De hecho, hay informes que indican que muchos ensayos cl\u00ednicos no est\u00e1n suficientemente dise\u00f1ados, lo que produce resultados ambiguos o in\u00fatiles [1-3]. Otros problemas, como el reclutamiento de suficientes pacientes para que el tama\u00f1o de la muestra sea el correcto [4], el sesgo y las percepciones durante el reclutamiento [2, 5], la retirada de pacientes de un ensayo [5, 6], la falta de transparencia o la ausencia de una revisi\u00f3n de expertos suficiente [1, 7], son factores muy reales que pueden confundir el estudio y dificultar la obtenci\u00f3n de conclusiones claras. Adem\u00e1s, la validaci\u00f3n de los f\u00e1rmacos suele continuar despu\u00e9s de su aprobaci\u00f3n para el mercado, a nivel poblacional, donde los efectos raros, adversos o fuera del objetivo s\u00f3lo se observan con un tama\u00f1o de muestra enorme y durante per\u00edodos de tiempo m\u00e1s largos [8].\u00a0<\/span><\/p>\n

Todo el proceso de desarrollo de un f\u00e1rmaco es largo y arduo porque implica pruebas rigurosas de eficacia y seguridad en humanos. Sin embargo, este proceso es necesario para ofrecer al p\u00fablico un perfil razonablemente completo del nuevo medicamento o de un medicamento existente utilizado para una nueva indicaci\u00f3n. El rigor en los ensayos cl\u00ednicos tambi\u00e9n es necesario para minimizar tragedias como las del <\/span>juicio BIA 10-2474 [9, 10], el <\/span>Ensayo con Theralizumab [11], <\/span>el ensayo de terapia g\u00e9nica para la deficiencia de ornitina transcarbamilasa (OTC) [12], <\/span>y la cat\u00e1strofe de la talidomida durante los a\u00f1os 50 y 60 [13].\u00a0<\/span><\/p>\n

Cada tragedia ha dado lugar a muchos esfuerzos por parte de la comunidad cient\u00edfica, las instituciones m\u00e9dicas y los organismos gubernamentales para aumentar la comunicaci\u00f3n, la consulta y reconocer los problemas desde el principio para evitar da\u00f1os y evaluar mejor la aplicabilidad de futuros ensayos [14-17]. Sin embargo, el proceso que va desde el descubrimiento de un f\u00e1rmaco hasta su comercializaci\u00f3n dista mucho de ser perfecto. Durante los \u00faltimos meses, el mundo ha sido testigo de la complejidad y, a menudo, la falta de conclusi\u00f3n de los estudios cient\u00edficos. Con la reciente noticia de los resultados positivos del ensayo de Remdesivir en pacientes con COVID-19 grave y la aprobaci\u00f3n acelerada del f\u00e1rmaco por parte de la FDA [18, 19], debemos recordar que a\u00fan queda trabajo por hacer.\u00a0<\/span><\/p>\n

    \n
  1. Ioannidis, J.P., <\/span>Why Most Clinical Investigar<\/a> Is Not Useful.<\/span><\/i> PLoS Med, 2016. 13(6): p. e1002049.<\/span><\/li>\n
  2. Treweek, S. y M. Zwarenstein, <\/span>Hacer que los ensayos sean importantes: los ensayos pragm\u00e1ticos y explicativos y el problema de la aplicabilidad.<\/span><\/i> Ensayos, 2009. 10: p. 37.<\/span><\/li>\n
  3. Slattery, P., A.K. Saeri y P. Bragge, <\/span>Co-dise\u00f1o de la investigaci\u00f3n en salud: una visi\u00f3n r\u00e1pida de las revisiones.<\/span><\/i> Health Res Policy Syst, 2020. 18(1): p. 17.<\/span><\/li>\n
  4. Reynolds, T., <\/span>Ensayos cl\u00ednicos: \u00bfpuede la tecnolog\u00eda resolver el problema del bajo reclutamiento?<\/span><\/i> BMJ, 2011. 342: p. d3662.<\/span><\/li>\n
  5. Lehmann, B.A., y otros, <\/span>\"Y entonces entr\u00f3 en el grupo equivocado\": Un estudio cualitativo que explora los efectos de la aleatorizaci\u00f3n en el reclutamiento de un ensayo controlado aleatorio.<\/span><\/i> Int J Environ Res Public Health, 2020. 17(6).<\/span><\/li>\n
  6. Cleland , J.G.F., y otros, <\/span>Un m\u00e9todo para reducir la p\u00e9rdida de seguimiento en los ensayos cl\u00ednicos: la retirada del consentimiento informado.<\/span><\/i> Revista Europea de Insuficiencia Card\u00edaca 2004. 6<\/span><\/li>\n<\/ol>\n

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

      \n
    1. Miyakawa, T., <\/span>Sin datos brutos, no hay ciencia: otra posible fuente de la crisis de reproducibilidad.<\/span><\/i> Mol Brain, 2020. <\/span>13<\/b>(1): p. 24.<\/span><\/li>\n
    2. Raj, N., y otros, <\/span>Vigilancia postcomercializaci\u00f3n: una revisi\u00f3n de los aspectos clave y las medidas sobre el funcionamiento efectivo en el contexto del Reino Unido y Canad\u00e1.<\/span><\/i> Ther Adv Drug Saf, 2019. <\/span>10<\/b>: p. 2042098619865413.<\/span><\/li>\n
    3. Randerson, J., <\/span>Un ensayo cl\u00ednico franc\u00e9s fatal no comprob\u00f3 los datos antes de aumentar la dosis del f\u00e1rmaco.<\/span><\/i> Nature News, 2016.<\/span><\/li>\n
    4. Kaur, R., P. Sidhu y S. Singh, <\/span>\u00bfQu\u00e9 ensayo cl\u00ednico de fase I del BIA 10-2474 fracas\u00f3? Especulaciones globales y recomendaciones para futuros ensayos de fase I.<\/span><\/i> J Pharmacol Pharmacother, 2016. <\/span>7<\/b>(3): p. 120-6.<\/span><\/li>\n
    5. Attarwala, H., <\/span>TGN1412: Del descubrimiento al desastre.<\/span><\/i> J Young Pharm, 2010. <\/span>2<\/b>(3): p. 332-6.<\/span><\/li>\n
    6. Rinde, M., <\/span>La muerte de Jesse Gelsinger, 20 a\u00f1os despu\u00e9s<\/span><\/i>, en <\/span>Instituto de Historia de la Ciencia - Destilaciones<\/span><\/i>. 2019.<\/span><\/li>\n
    7. Vargesson, N., <\/span>Teratog\u00e9nesis inducida por talidomida: historia y mecanismos.<\/span><\/i> Birth Defects Res C Embryo Today, 2015. <\/span>105<\/b>(2): p. 140-56.<\/span><\/li>\n
    8. Lipman, P.D., L. Dluzak y C.M. Stoney, <\/span>\u00bfEs factible este estudio? Facilitar la gesti\u00f3n de los hitos de planificaci\u00f3n de los ensayos pragm\u00e1ticos en el marco de un mecanismo de financiaci\u00f3n por fases.<\/span><\/i> Pruebas, 2019. <\/span>20<\/b>(1): p. 307.<\/span><\/li>\n
    9. Dal-R\u00e9, R., P. Janiaud y J.P.A. Ioannidis, <\/span>Pruebas del mundo real: \u00bfHasta qu\u00e9 punto son pragm\u00e1ticos los ensayos controlados aleatorios etiquetados como pragm\u00e1ticos?<\/span><\/i> BMC Med, 2018. <\/span>16<\/b>(1): p. 49.<\/span><\/li>\n
    10. Reijers, J.A.A., y otros, <\/span>Inmunoestimulaci\u00f3n adversa causada por impurezas: El lado oscuro de los biof\u00e1rmacos.<\/span><\/i> Br J Clin Pharmacol, 2019. <\/span>85<\/b>(7): p. 1418-1426.<\/span><\/li>\n
    11. Van Norman, G.A., <\/span>Limitaciones de los estudios con animales para predecir la toxicidad en los ensayos cl\u00ednicos: \u00bfHa llegado el momento de reconsiderar nuestro enfoque actual?<\/span><\/i> JACC Basic Transl Sci, 2019. <\/span>4<\/b>(7): p. 845-854.<\/span><\/li>\n
    12. Enfermedades, N.I.o.A.a.I., <\/span>Un ensayo cl\u00ednico de los NIH demuestra que Remdesivir acelera la recuperaci\u00f3n de la COVID-19 avanzada<\/span><\/i>, N.I.o. Health, Editor. 2020.<\/span><\/li>\n
    13. Gilead, <\/span>Gilead anuncia los resultados del ensayo de fase 3 del antiviral en investigaci\u00f3n Remdesivir en pacientes con COVID-19 grave<\/span><\/i>, Gilead, Editor. 2020.<\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"

      Los estudios cient\u00edficos se dise\u00f1an con una serie de experimentos de control y r\u00e9plicas de manera que la respuesta a la pregunta investigada sea clara. En los montajes experimentales complejos, como los ensayos cl\u00ednicos, los resultados suelen ser menos claros, lo que hace imposible la extrapolaci\u00f3n de los datos [1]. De hecho, hay informes que indican que muchos ensayos cl\u00ednicos no est\u00e1n suficientemente dise\u00f1ados, lo que da lugar a resultados ambiguos<\/p>\n

      Leer m\u00e1s<\/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\/es\/the-difficulties-in-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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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