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Sistema de calidad por diseño habilitado por blockchain para ensayos clínicos

Reza Vatankhah Barenji¹, Reza Ebrahimi Hariry²

¹Department of Engineering, School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom.

Frontiers in medicine

|December 22, 2025

Resumen

La tecnología blockchain mejora la calidad por diseño (QbD) de los ensayos clínicos al mejorar la integridad de los datos y la seguridad de los participantes. Este enfoque seguro y distribuido aumenta la coherencia de los datos y la verificación de procesos para una mejor gestión de los ensayos.

Palabras clave:

PDCA tecnología blockchain ensayos clínicos desarrollo de fármacos calidad por diseño

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Área de la Ciencia:

Investigación Clínica
Gestión de Datos
Tecnología de la Información

Sus antecedentes:

La Calidad por Diseño (QbD) es crucial para la integridad de los ensayos clínicos.
La gestión actual de datos en los ensayos enfrenta desafíos en integridad y transparencia.
La tecnología blockchain ofrece una solución novedosa para el manejo de datos seguro y distribuido.

Objetivo del estudio:

Desarrollar y evaluar una arquitectura de Calidad por Diseño (QbD) habilitada por blockchain para ensayos clínicos.
Mejorar la integridad de los datos, la seguridad de los participantes y la trazabilidad dentro de los procesos de ensayos clínicos.
Demostrar la viabilidad y escalabilidad de la integración de blockchain en la gestión de datos clínicos.

Principales métodos:

Desarrollo de una arquitectura de QbD habilitada por blockchain.
Implementación de un prototipo utilizando Hyperledger Fabric.
Evaluación de la aplicabilidad del sistema utilizando datos de ensayos clínicos piloto.

Principales resultados:

La arquitectura facilitó el intercambio inmutable de datos y mejoró la trazabilidad de las actividades de QbD.
Se apoyó la colaboración segura entre las partes interesadas.
Mejora de la coherencia de los datos y verificación automatizada de los procesos del ensayo.

Conclusiones:

La tecnología blockchain mejora eficazmente la implementación de QbD en ensayos clínicos.
La arquitectura propuesta mejora la integración de datos, la transparencia y la monitorización de la seguridad.
Este modelo ofrece una solución factible y escalable para futuros sistemas de gestión de datos clínicos.