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Cómo la farmacología clínica puede apoyar la diversidad e inclusión en los ensayos clínicos

Michael Z Liao¹, Aarti Sawant², Brian Corrigan³

¹Genentech, Inc., South San Francisco, California, USA.

Clinical and translational science

|August 26, 2025

Resumen

El logro de la diversidad de ensayos clínicos requiere colaboración y la utilización de herramientas de farmacología clínica para incluir a poblaciones subrepresentadas. Este enfoque asegura que las terapias futuras sean seguras, efectivas y equitativas para todos.

Área de la Ciencia:

Farmacología clínica
Desarrollo de drogas
Equidad en salud

Sus antecedentes:

El reclutamiento de diversas poblaciones en los primeros ensayos clínicos presenta desafíos.
El desarrollo de planes de diversidad requiere una implementación estratégica.
El Grupo de Trabajo del Grupo de Liderazgo de Farmacología Clínica de Diversidad e Inclusión (D&I CPLG WG) y la Sociedad Americana de Farmacología Clínica y Terapéutica (ASCPT) abordaron estas cuestiones.

Objetivo del estudio:

Desarrollar estrategias para mejorar la participación de poblaciones subrepresentadas en ensayos clínicos.
Utilizar herramientas de farmacología clínica y orientación sobre planes de diversidad.
Promover la colaboración entre la industria, los reguladores y el mundo académico.

Principales métodos:

Una sesión previa a la conferencia con oradores de la industria, los reguladores y el IQ.
Conferencias de última generación y estudios de casos sobre la diversidad y la inclusión en ensayos.
Discusiones sobre estrategias de farmacología clínica, incluido el desarrollo de fármacos basado en modelos (MIDD) y la farmacogenética traslacional.

Principales resultados:

La preconferencia involucró con éxito a la industria, el mundo académico y los reguladores.
Se abordaron cuestiones clave relativas a las poblaciones subrepresentadas y a la evaluación de la relación beneficio-riesgo.
Se proporcionaron datos sobre la evaluación de factores demográficos y biológicos (edad, origen étnico, deterioro de órganos, metabolismo, transportadores, farmacogenética) en ensayos clínicos.

Conclusiones:

El logro de la diversidad en los ensayos clínicos es un desafío complejo que requiere esfuerzos sostenidos en todo el ecosistema.
Los farmacólogos clínicos son fundamentales para liderar la transformación hacia el desarrollo equitativo de medicamentos.
El compromiso con la equidad y la participación de la comunidad es esencial para el éxito.

Palabras clave:

diversidad e inclusión Enfermedad de edad avanzada Disfunción de los órganos farmacogenética Medicina de precisión raza y origen étnico

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