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Factores asociados con la falta de publicación de grandes ensayos aleatorizados presentados en una reunión de
Monika K Krzyzanowska1, Melania Pintilie, Ian F Tannock
1Center for Outcomes and Policy Research, Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Mass, USA.
JAMA
|July 24, 2003
Resumen
Muchos grandes ensayos clínicos permanecen sin publicar 5 años después de la presentación, con un sesgo en contra de la publicación de resultados no significativos. Esto tiene un impacto en la literatura médica y en las decisiones de atención al paciente.
Área de la Ciencia:
- Los ensayos clínicos son ensayos clínicos.
- Investigación en Oncología Investigación en Oncología.
- El sesgo de la publicación.
Sus antecedentes:
- Los grandes ensayos clínicos son cruciales para las decisiones de tratamiento.
- La no publicación de los resultados de los ensayos puede introducir sesgos y conducir a elecciones médicas subóptimas.
Objetivo del estudio:
- Evaluar la tasa de publicación completa de los grandes ensayos aleatorizados presentados en las reuniones de la Sociedad Americana de Oncología Clínica (ASCO).
- Para cuantificar el sesgo de publicación frente a hallazgos no significativos.
- Identificar los factores que influyen en el tiempo de publicación.
Principales métodos:
- Una encuesta de 510 grandes (>= 200 participantes), ensayos controlados aleatorizados de fase 3, presentados en las reuniones de ASCO (1989-1998).
- Clasificación de los resultados del ensayo como significativos (P<=.05) o no significativos (P>.05).
- Estatus de publicación completo seguido a través de MEDLINE, EMBASE y el Registro Cochrane hasta noviembre de 2002; los autores contactados si no se publican.
Principales resultados:
- El veintiséis por ciento de los grandes ensayos aleatorizados no se publicaron completamente dentro de los 5 años de presentación.
- Los ensayos con resultados significativos tuvieron tasas de publicación más altas (81%) que aquellos con resultados no significativos (68%).
- Las presentaciones orales/plenarias y el patrocinio farmacéutico se asociaron con tiempos de publicación más rápidos.
Conclusiones:
- Una proporción significativa de los grandes ensayos oncológicos permanecen sin publicar 5 años después de la presentación.
- El sesgo de publicación contra los resultados no significativos persiste incluso en ensayos grandes y de alto impacto.
- La no publicación socava las obligaciones éticas para con los participantes, financiadores y juntas de revisión.
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