Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018

ilustraciones, diagramas, gráficas, tablas

Autores:
Bocanegra Perilla, Luis Alejandro
Tipo de recurso:
Fecha de publicación:
2023
Institución:
Universidad Nacional de Colombia
Repositorio:
Universidad Nacional de Colombia
Idioma:
spa
OAI Identifier:
oai:repositorio.unal.edu.co:unal/84469
Acceso en línea:
https://repositorio.unal.edu.co/handle/unal/84469
https://repositorio.unal.edu.co/
Palabra clave:
610 - Medicina y salud
Preparaciones Farmacéuticas
Biosimilares Farmacéuticos
Pharmaceutical Preparations
Biosimilar Pharmaceuticals
Oncología Médica
Productos Biológicos
Inmunoterapia
Aprobación de Medicamentos
Neoplasias
Biological Products
Medical Oncology
Immunotherapy
Drug Approval
Neoplasms
Rights
openAccess
License
Atribución-NoComercial 4.0 Internacional
id UNACIONAL2_f103fd4bd4dc334b1e20d7a99ba7d149
oai_identifier_str oai:repositorio.unal.edu.co:unal/84469
network_acronym_str UNACIONAL2
network_name_str Universidad Nacional de Colombia
repository_id_str
dc.title.spa.fl_str_mv Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
dc.title.translated.eng.fl_str_mv Assessment of the clinical evidence of new indications in oncology granted to biological drugs prevously registered in the FDA (Efficacy Supplements): Retrospective analysis 2016-2018
title Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
spellingShingle Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
610 - Medicina y salud
Preparaciones Farmacéuticas
Biosimilares Farmacéuticos
Pharmaceutical Preparations
Biosimilar Pharmaceuticals
Oncología Médica
Productos Biológicos
Inmunoterapia
Aprobación de Medicamentos
Neoplasias
Biological Products
Medical Oncology
Immunotherapy
Drug Approval
Neoplasms
title_short Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
title_full Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
title_fullStr Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
title_full_unstemmed Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
title_sort Evaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018
dc.creator.fl_str_mv Bocanegra Perilla, Luis Alejandro
dc.contributor.advisor.none.fl_str_mv Orozco Díaz, Jose Gilberto
dc.contributor.author.none.fl_str_mv Bocanegra Perilla, Luis Alejandro
dc.contributor.researchgroup.spa.fl_str_mv Ram (Red Para El Uso Adecuado de Medicamentos)
dc.subject.ddc.spa.fl_str_mv 610 - Medicina y salud
topic 610 - Medicina y salud
Preparaciones Farmacéuticas
Biosimilares Farmacéuticos
Pharmaceutical Preparations
Biosimilar Pharmaceuticals
Oncología Médica
Productos Biológicos
Inmunoterapia
Aprobación de Medicamentos
Neoplasias
Biological Products
Medical Oncology
Immunotherapy
Drug Approval
Neoplasms
dc.subject.decs.spa.fl_str_mv Preparaciones Farmacéuticas
Biosimilares Farmacéuticos
dc.subject.decs.eng.fl_str_mv Pharmaceutical Preparations
Biosimilar Pharmaceuticals
dc.subject.proposal.spa.fl_str_mv Oncología Médica
Productos Biológicos
Inmunoterapia
Aprobación de Medicamentos
Neoplasias
dc.subject.proposal.eng.fl_str_mv Biological Products
Medical Oncology
Immunotherapy
Drug Approval
Neoplasms
description ilustraciones, diagramas, gráficas, tablas
publishDate 2023
dc.date.accessioned.none.fl_str_mv 2023-08-08T13:23:50Z
dc.date.available.none.fl_str_mv 2023-08-08T13:23:50Z
dc.date.issued.none.fl_str_mv 2023-08-05
dc.type.spa.fl_str_mv Trabajo de grado - Maestría
dc.type.driver.spa.fl_str_mv info:eu-repo/semantics/masterThesis
dc.type.version.spa.fl_str_mv info:eu-repo/semantics/acceptedVersion
dc.type.content.spa.fl_str_mv Text
dc.type.redcol.spa.fl_str_mv http://purl.org/redcol/resource_type/TM
status_str acceptedVersion
dc.identifier.uri.none.fl_str_mv https://repositorio.unal.edu.co/handle/unal/84469
dc.identifier.instname.spa.fl_str_mv Universidad Nacional de Colombia
dc.identifier.reponame.spa.fl_str_mv Repositorio Institucional Universidad Nacional de Colombia
dc.identifier.repourl.spa.fl_str_mv https://repositorio.unal.edu.co/
url https://repositorio.unal.edu.co/handle/unal/84469
https://repositorio.unal.edu.co/
identifier_str_mv Universidad Nacional de Colombia
Repositorio Institucional Universidad Nacional de Colombia
dc.language.iso.spa.fl_str_mv spa
language spa
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dc.rights.license.spa.fl_str_mv Atribución-NoComercial 4.0 Internacional
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dc.format.extent.spa.fl_str_mv xviii, 155 páginas
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dc.publisher.spa.fl_str_mv Universidad Nacional de Colombia
dc.publisher.program.spa.fl_str_mv Bogotá - Ciencias - Maestría en Ciencias - Farmacología
dc.publisher.faculty.spa.fl_str_mv Facultad de Ciencias
dc.publisher.place.spa.fl_str_mv Bogotá, Colombia
dc.publisher.branch.spa.fl_str_mv Universidad Nacional de Colombia - Sede Bogotá
institution Universidad Nacional de Colombia
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spelling Atribución-NoComercial 4.0 InternacionalDerechos reservados al autor, 2023http://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Orozco Díaz, Jose Gilbertod907b3c5f5e30cb8d9d122f39814f787Bocanegra Perilla, Luis Alejandro07b209ee96cde723f71ceda5fe35b105Ram (Red Para El Uso Adecuado de Medicamentos)2023-08-08T13:23:50Z2023-08-08T13:23:50Z2023-08-05https://repositorio.unal.edu.co/handle/unal/84469Universidad Nacional de ColombiaRepositorio Institucional Universidad Nacional de Colombiahttps://repositorio.unal.edu.co/ilustraciones, diagramas, gráficas, tablasIntroducción: La investigación de nuevas indicaciones para medicamentos biológicos en oncología ha sido fundamental para mejorar el abordaje en el tratamiento del cáncer. Sin embargo, han surgido inquietudes relacionadas con la evidencia clínica soporte de dichas indicaciones. Objetivo: El interés de esta investigación consistió en evaluar la calidad metodológica de los ensayos clínicos soporte de nuevas indicaciones otorgadas a medicamentos biológicos previamente aprobados por la FDA (Efficacy Supplements) durante los años 2016-2018. Metodología: Se realizó un estudio observacional retrospectivo de corte transversal seleccionando el conjunto de nuevas aprobaciones de la FDA a productos biológicos (BLA Efficacy Supplements), correspondientes a nuevas indicaciones en oncología para los años 2016 a 2018. Se describieron las características de los ensayos clínicos soporte de aprobación de dichas indicaciones, se evaluó el riesgo de sesgo con la ayuda de la herramienta RoB2 revisada por Cochrane y se determinó la magnitud del beneficio clínico con la aplicación de la Escala de Magnitud de Beneficio Clínico versión 1.1 desarrollada por la ESMO. Resultados: Se identificaron un total de 37 aprobaciones asociadas a agentes inmunoterapéuticos, empleados en su mayoría en combinación con otros tratamientos. Los ensayos clínicos se caracterizaron por presentar algunos reparos en su calidad metodológica, con la ausencia de aleatorización (43.2%), cegamiento (86.5%) y grupo control (43.2%) en un amplio porcentaje de ensayos, lo que llevo a considerar al 59.5% de los ensayos clínicos soporte de aprobación con un alto riesgo de sesgo. El beneficio clínico sustancial se determinó solo en el 16.2% de las indicaciones aprobadas. Conclusión: El conjunto de ensayos clínicos analizados en esta investigación se compuso de una gran proporción de ensayos con alto riesgo de sesgo y un reducido tamaño del beneficio clínico. Se concluye a su vez que el sistema de investigación y aprobación de medicamentos oncológicos debe ser cuidadosamente examinado ya que la evidencia clínica parece limitada en calidad metodológica y magnitud del beneficio clínico modesta. (Texto tomado de la fuente)Background: The research of new indications for biological drugs in oncology has been essential to improve the approach in the treatment of cancer. However, concerns have been raised regarding the clinical evidence supporting these indications. Objective: The purpose of this research consisted in evaluating the methodological quality of clinical trials supporting new indications granted to biological drugs previously approved by the FDA (Efficacy Supplements) during the years 2016-2018. Methodology: A retrospective cross-sectional observational study was carried out selecting the set of new FDA approvals for biological products (BLA Efficacy Supplements), corresponding to new indications in oncology for the period 2016 to 2018. The characteristics of the clinical trials supporting the approval of these indications, the risk of bias was assessed with the help of the RoB2 tool reviewed by Cochrane and the magnitude of the clinical benefit was determined with the application of the Magnitude of Clinical Benefit Scale version 1.1 developed by ESMO. Results: A total of 37 approvals associated with immunotherapeutic agents were identified, mostly used in combination with other treatments. The clinical trials were characterized by presenting some objections in their methodological quality, with the absence of randomization (43.2%), blinding (86.5%) and control group (43.2%) in a large percentage of trials, which led to considering 59.5 % of approval support clinical trials with a high risk of bias. Substantial clinical benefit was determined in only 16.2% of the approved indications. Conclusion: The set of clinical trials analyzed in this investigation consisted of a large proportion of trials with a high risk of bias and a small size of clinical benefit. On the other hand, it is concluded that the system for research and approval of oncological drugs must be carefully examined since the clinical evidence seems limited in methodological quality and magnitude of modest clinical benefit.incluye anexosMaestríaMagíster en Ciencias - FarmacologíaSe realizó un estudio observacional retrospectivo de corte transversal seleccionando el conjunto de nuevas aprobaciones de la FDA a productos biológicos (BLA Efficacy Supplements), correspondientes a nuevas indicaciones en oncología para los años 2016 a 2018. Se describieron las características de los ensayos clínicos soporte de aprobación de dichas indicaciones, se evaluó el riesgo de sesgo con la ayuda de la herramienta RoB2 revisada por Cochrane y se determinó la magnitud del beneficio clínico con la aplicación de la Escala de Magnitud de Beneficio Clínico versión 1.1 desarrollada por la ESMO.Farmacovigilanciaxviii, 155 páginasapplication/pdfspaUniversidad Nacional de ColombiaBogotá - Ciencias - Maestría en Ciencias - FarmacologíaFacultad de CienciasBogotá, ColombiaUniversidad Nacional de Colombia - Sede Bogotá610 - Medicina y saludPreparaciones FarmacéuticasBiosimilares FarmacéuticosPharmaceutical PreparationsBiosimilar PharmaceuticalsOncología MédicaProductos BiológicosInmunoterapiaAprobación de MedicamentosNeoplasiasBiological ProductsMedical OncologyImmunotherapyDrug ApprovalNeoplasmsEvaluación de la evidencia clínica de nuevas indicaciones en oncología otorgadas a medicamentos biológicos previamente registrados en la FDA (Efficacy Supplements): Análisis retrospectivo 2016-2018Assessment of the clinical evidence of new indications in oncology granted to biological drugs prevously registered in the FDA (Efficacy Supplements): Retrospective analysis 2016-2018Trabajo de grado - Maestríainfo:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/acceptedVersionTexthttp://purl.org/redcol/resource_type/TM1. 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