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Compromiso entre beneficios y riesgos en la evaluación de nuevos fármacos y dispositivos
Sanjay Kaul1, Norman Stockbridge2, Javed Butler3
1Department of Cardiology, Cedars-Sinai Medical Center, and the David Geffen School of Medicine, University of California, Los Angeles (S.K.).
Circulation
|November 16, 2020
Resumen
La evaluación del perfil beneficio-riesgo de las intervenciones médicas es crucial. Este documento explora métodos cualitativos y cuantitativos para evaluar y comunicar estos perfiles, ayudando a la toma de decisiones informada.
Área de la Ciencia:
- La toma de decisiones médicas
- Ciencias de la regulación
- Economía de la salud
Sus antecedentes:
- Equilibrar los beneficios médicos y los riesgos es un desafío importante para los organismos reguladores y la práctica clínica.
- La evaluación y la comunicación eficaces de los perfiles beneficio-riesgo son esenciales para los nuevos medicamentos y productos.
Objetivo del estudio:
- Describir los enfoques cualitativos y cuantitativos para la evaluación del beneficio-riesgo.
- Proporcionar ejemplos ilustrativos de las evaluaciones de beneficio-riesgo para diversos tratamientos.
Principales métodos:
- Enfoques cualitativos: el marco del Equipo de Acción de Riesgo de Beneficio (BRAT), el Marco de Beneficio-Riesgo (BRF).
- Enfoques cuantitativos: Números necesarios para tratar (NNT) para beneficio y daño, relación beneficio-riesgo (BRR), beneficio neto incremental (INB).
- Ejemplos ilustrativos: inhibidores de SGLT2 (diabetes), dabigatrán (fibrilación auricular), TAVR (estenosis aórtica), vorapaxar/prasugrel (eventos cardiovasculares), entre otros.
Principales resultados:
- El documento describe los métodos estructurados para evaluar los perfiles de beneficio-riesgo.
- Ejemplos ilustrativos demuestran la aplicación de estos métodos en diversas áreas terapéuticas.
- Las presentaciones gráficas pueden ayudar a capturar las incertidumbres en las métricas de beneficio-riesgo.
Conclusiones:
- La evaluación estructurada del riesgo-beneficio, que utiliza enfoques cualitativos, cuantitativos o combinados, mejora la transparencia.
- Las presentaciones gráficas fáciles de entender pueden apoyar la toma de decisiones compartida entre médicos y pacientes.
- La aplicación regular de estas herramientas de evaluación puede mejorar la toma de decisiones terapéuticas y las evaluaciones regulatorias.
Palabras clave:
Valoración de los riesgos y beneficiosEnfermedad cardiovascularensayo clínicoMedicina basada en la evidenciaanálisis estadísticoMás Videos Relacionados
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