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Endpoints sustitutos en la toma de decisiones regulatorias

Linda J B Jeng1, Jeffrey Siegel2

  • 1Division of Biomedical Informatics, Research, and Biomarker Development, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.

Clinical and translational science
|December 19, 2025
PubMed
Resumen

La FDA necesita pruebas sólidas de que los medicamentos mejoran el bienestar, la función o la supervivencia de los pacientes. Los biomarcadores utilizados como endpoints sustitutos (SE) pueden acelerar el desarrollo de nuevos medicamentos para necesidades no cubiertas.

Palabras clave:
biomarcadoresdesarrollo de fármacosendpoints sustitutos

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Área de la Ciencia:

  • Farmacología; Investigación Clínica; Biomarcadores

Sus antecedentes:

  • La aprobación de medicamentos requiere pruebas sustanciales de eficacia.
  • La eficacia debe demostrar mejoras en cómo los pacientes se sienten, funcionan o sobreviven.
  • Los resultados clínicos pueden medirse directa o indirectamente.

Objetivo del estudio:

  • Explicar los requisitos de la FDA para la eficacia de los medicamentos.
  • Destacar el papel de los endpoints sustitutos (SE) en el desarrollo de fármacos.
  • Enfatizar el potencial de los biomarcadores como SE.

Principales métodos:

  • Revisión de los requisitos de eficacia de la FDA.
  • Explicación de la medición de resultados directa e indirecta.
  • Discusión de endpoints sustitutos (SE) y biomarcadores.

Principales resultados:

  • La FDA exige pruebas sustanciales para la aprobación de medicamentos.
  • La eficacia se evalúa mediante resultados informados por el paciente o endpoints sustitutos (SE).
  • Los biomarcadores pueden servir como SE eficaces.

Conclusiones:

  • Los biomarcadores como SE pueden acelerar el desarrollo de fármacos.
  • Esto es particularmente importante para afecciones con necesidades médicas no cubiertas.
  • La utilización de biomarcadores como SE se alinea con los requisitos de evidencia de la FDA.