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Medir la representatividad en los ensayos clínicos

Allen Sanyi1,2, Samuel Byiringiro3, Sanaz Dabiri4

  • 1Department of Medicine (A.S.), Emory University School of Medicine, Atlanta, GA.

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|February 3, 2025
PubMed
Resumen
Este resumen es generado por máquina.

La medición de la representatividad en los ensayos clínicos es crucial para la investigación equitativa. Si bien ningún método es perfecto, un enfoque multifacético puede mejorar la diversidad, la equidad, la inclusión y la pertenencia (DEIB) en los ensayos.

Palabras clave:
ensayos clínicosdiversidad, equidad, inclusión y pertenenciareclutamiento de pacienteslas minorías raciales y étnicas

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Área de la Ciencia:

  • Ensayos clínicos
  • Equidad en salud
  • Metodología de la investigación

Sus antecedentes:

  • La representatividad en los ensayos clínicos es vital para la validez externa, el acceso equitativo a la investigación y la confianza del público.
  • La cuantificación de la representatividad es un paso clave para lograr la diversidad, la equidad, la inclusión y la pertenencia (DEIB) en la investigación clínica.
  • La subrepresentación tradicional de ciertos grupos en los ensayos requiere estrategias de medición sólidas.

Objetivo del estudio:

  • Explorar varios métodos cuantitativos para medir la representatividad en ensayos clínicos aleatorizados.
  • Evaluar las fortalezas y debilidades de los diferentes enfoques para evaluar la demografía de los participantes en el ensayo.
  • Informar a las partes interesadas sobre la selección de indicadores apropiados para evaluar y mejorar el DEIB en la investigación clínica.

Principales métodos:

  • Revisión de los métodos propuestos para medir la representatividad del ensayo, incluida la relación participación/prevalencia y las fracciones de inscripción.
  • Análisis de la utilidad de las diferentes medidas cuantitativas en función de las necesidades de las partes interesadas y de los contextos de los ensayos.
  • Consideración de las posibles consecuencias imprevistas del uso de objetivos de representatividad cuantitativa.

Principales resultados:

  • Existen múltiples métodos para medir la representatividad, cada uno con limitaciones.
  • La relación participación-prevalencia es útil para ensayos con datos demográficos bien definidos.
  • Una combinación de fracciones de inscripción y informes demográficos ofrece una visión más matizada de la representatividad.

Conclusiones:

  • Ningún método único aborda de manera exhaustiva el DEIB en todos los ensayos clínicos.
  • Se recomienda un enfoque multifacético y cuidadosamente diseñado para medir la representatividad.
  • Las medidas cuantitativas pueden orientar los esfuerzos para aumentar la diversidad en la participación en ensayos clínicos cuando se utilizan de manera reflexiva.