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Published on: September 19, 2012
El principio de incertidumbre y la investigación patrocinada por la industria
B Djulbegovic1, M Lacevic, A Cantor
1Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA. djulbebm@moffitt.usf.edu
Lancet (London, England)
|September 1, 2000
Resumen
El financiamiento de la industria farmacéutica de los ensayos clínicos puede introducir sesgo. Los estudios financiados por organizaciones sin fines de lucro respaldan mejor el principio de incertidumbre, asegurando comparaciones más justas de tratamientos.
Área de la Ciencia:
- Metodología de ensayos clínicos Metodología de ensayos clínicos.
- Ética en la investigación médica Ética en la investigación médica
- Supervisión de la Industria Farmacéutica La Supervisión de la Industria Farmacéutica es la supervisión de la industria farmacéutica.
Sus antecedentes:
- Los ensayos clínicos aleatorizados (ECA) patrocinados por la industria farmacéutica se enfrentan al escrutinio de posibles sesgos.
- Los sesgos pueden surgir de la presentación de informes selectivos o la publicación de estudios de baja calidad con resultados desfavorables.
- El principio de incertidumbre obliga a los ECA sólo cuando existe una verdadera incertidumbre con respecto a la eficacia del tratamiento.
Objetivo del estudio:
- Evaluar el cumplimiento del principio de incertidumbre en 136 ECA publicados.
- Analizar el impacto de la fuente de financiación en la calidad del ensayo y el cumplimiento del principio de incertidumbre.
- Para investigar el sesgo potencial en la investigación patrocinada por la industria farmacéutica.
Principales métodos:
- Examinó 136 ECA en mieloma múltiple para la adhesión al principio de incertidumbre.
- Se comparó la proporción de estudios que favorecían el tratamiento experimental frente al estándar.
- Analizó la calidad del ensayo y la adherencia en función de la fuente de financiación (con fines de lucro vs. sin fines de lucro).
Principales resultados:
- Los ensayos financiados en parte o en su totalidad por organizaciones con fines de lucro mostraron una tendencia hacia puntuaciones de calidad más altas (p = 0,06).
- Los estudios financiados por organizaciones sin fines de lucro mantienen mejor el equilibrio (47% vs. 53% que favorecen nuevas terapias, p=0,608).
- Los ensayos financiados con fines de lucro mostraron un sesgo significativo hacia los tratamientos experimentales (74% frente a 26%, p = 0,004).
Conclusiones:
- Las violaciones del principio de incertidumbre pueden explicar el sesgo reportado en la investigación patrocinada por la industria farmacéutica.
- El fomento de informes transparentes y controles comparativos apropiados es crucial para los patrocinadores de ensayos clínicos.
- Asegurar el equilibrio en el diseño del ensayo es esencial para obtener resultados de investigación imparciales.
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