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Costos incrementales del tratamiento en ensayos clínicos patrocinados por el Instituto Nacional del Cáncer
Dana P Goldman1, Sandra H Berry, Mary S McCabe
1RAND Health, 1700 Main St, Santa Monica, CA 90407-2138, USA. Dana_Goldman@rand.org
JAMA
|June 12, 2003
Resumen
La participación en ensayos clínicos para pacientes con cáncer incurre en costos adicionales de atención directa modestos, en promedio un 6,5% más altos que los no participantes. Estos costos fueron más altos en los ensayos de fase temprana y para los pacientes que murieron.
Área de la Ciencia:
- Oncología Oncología.
- Economía de la salud Economía de la salud
- La investigación clínica es la investigación clínica.
Sus antecedentes:
- Las preocupaciones sobre el aumento de los costos de atención al paciente a menudo dificultan la inscripción en ensayos clínicos.
- Existen pruebas limitadas para sustentar estas preocupaciones de costos en los ensayos clínicos de cáncer.
Objetivo del estudio:
- Evaluar los costos adicionales de atención directa al paciente para pacientes con cáncer en ensayos clínicos patrocinados por el Instituto Nacional del Cáncer (NCI).
- Para comparar los costos en diferentes fases de ensayo, tipos de tratamiento y entornos de atención en los Estados Unidos.
Principales métodos:
- Análisis retrospectivo de costos de 932 pacientes con cáncer en ensayos patrocinados por el NCI frente a 696 no participantes.
- Datos recopilados a través de registros médicos, encuestas y reclamos de Medicare de 83 instituciones estadounidenses.
- Centrado en los costos directos del tratamiento, excluidos los gastos administrativos y de investigación.
Principales resultados:
- Los costos de atención directa ajustados fueron un 6,5% más altos para los participantes en el ensayo durante ~ 2,5 años ($ 35,418 frente a $ 33,248).
- Los costos incrementales fueron más altos para los ensayos de fase temprana (fase 1/2) (12,8%) en comparación con la fase 3 (3,5%).
- Los costos fueron significativamente más altos para los participantes del ensayo que murieron (17,9%) en comparación con los no participantes que murieron.
Conclusiones:
- Los pacientes con cáncer en los ensayos patrocinados por el NCI incurren en aproximadamente un 6,5% más de costos de tratamiento directo.
- Los costos incrementales totales estimados para los ensayos del NIC en 1999 fueron de 16 millones de dólares.
- Los costos adicionales fueron mayores en los ensayos de fase temprana y para pacientes fallecidos, lo que sugiere un impacto mínimo de las políticas de reembolso abierto.
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