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Registro de los ensayos clínicos
Kay Dickersin1, Drummond Rennie
1Center for Clinical Trials and Evidence-based Healthcare, Brown Medical School, Providence, RI 02912, USA. kay_dickersin@brown.edu
JAMA
|July 24, 2003
Resumen
Asegurar que todos los ensayos clínicos estén registrados es crucial para evitar el sesgo de publicación y mantener la confianza del paciente. El registro integral de ensayos clínicos beneficia a los pacientes, médicos e investigadores al mejorar la accesibilidad de los datos y el avance del conocimiento médico.
Área de la Ciencia:
- Ética en la investigación médica Ética en la investigación médica
- Gestión de ensayos clínicos de gestión de ensayos clínicos
- Publicaciones científicas Publicaciones científicas
Sus antecedentes:
- La información incompleta sobre los ensayos clínicos iniciados es una preocupación mundial.
- El sesgo de publicación, donde se favorecen los resultados positivos sobre los negativos, distorsiona la evidencia médica.
- La falta de un registro exhaustivo de ensayos clínicos erosiona la confianza entre pacientes, investigadores y juntas de ética.
Objetivo del estudio:
- Para resaltar la necesidad crítica de un registro completo de ensayos clínicos.
- Abordar las implicaciones éticas de los datos de ensayos no revelados, particularmente en la investigación patrocinada por la industria.
- Abogar por una acción inmediata y colaborativa de todas las partes interesadas para garantizar el registro universal de los ensayos.
Principales métodos:
- Este estudio es un análisis conceptual y un argumento ético.
- Revisa las consecuencias del registro incompleto de ensayos clínicos.
- Examina el papel del sesgo de publicación y su impacto en el conocimiento médico.
Principales resultados:
- El hecho de no registrar todos los ensayos clínicos conduce a una comprensión sesgada de la investigación médica.
- Los resultados negativos o no concluyentes no revelados representan una violación ética significativa.
- La falta de transparencia afecta particularmente a los ensayos patrocinados por la industria donde están involucrados intereses financieros.
Conclusiones:
- El registro completo de ensayos clínicos es esencial para la integridad científica y la confianza del público.
- Todas las partes interesadas, incluidos investigadores, instituciones, editores y responsables políticos, deben priorizar el registro universal de ensayos.
- La implementación de identificadores únicos para todos los ensayos mejorará la accesibilidad de los datos y combatirá el sesgo de publicación, acelerando el progreso médico.
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