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Navegando las complejidades en ensayos aleatorizados: perspectivas del ensayo EMERGE en medio de la pandemia y la
Christine Newman1,2,3, Fidelma Dunne1,2,3, Alberto Alvarez-Iglesias2
1College of nursing, medicine and health science, University of Galway, Galway, County Galway, Ireland.
HRB open research
|January 12, 2026
Resumen
El ensayo Early Metformin in Gestational Diabetes (EMERGE) superó con éxito el COVID-19 y los ciberataques implementando estrategias flexibles. Esto aseguró la continuación del reclutamiento y la integridad de los datos para la investigación sobre diabetes mellitus gestacional.
Área de la Ciencia:
- Ensayos clínicos
- Salud pública
- Enfermedades infecciosas
Sus antecedentes:
- La pandemia de COVID-19 interrumpió significativamente las operaciones globales de ensayos clínicos, causando retrasos y terminaciones.
- El ensayo Early Metformin in Gestational Diabetes (EMERGE) enfrentó desafíos únicos, incluida la pandemia de COVID-19 y los ataques a redes informáticas (CNA).
Objetivo del estudio:
- Describir los desafíos y las soluciones para mantener el reclutamiento activo en una cohorte de pacientes de alto riesgo durante la pandemia de COVID-19.
- Detallar las técnicas adaptadas para el reclutamiento, la notificación de eventos adversos y la notificación de laboratorio durante dos CNA críticos.
- Presentar soluciones desde la perspectiva del sitio del ensayo clínico y del patrocinador.
Principales métodos:
- Se implementó la telemedicina y la videoconferencia para superar el trabajo remoto y la escasez de personal.
- Se utilizaron sistemas de respaldo basados en papel y rigurosas verificaciones de integridad de datos para gestionar las interrupciones del sistema causadas por los CNA.
- Se adaptaron las vías de diagnóstico y el monitoreo de pacientes para la diabetes mellitus gestacional en respuesta a las restricciones relacionadas con la pandemia.
Principales resultados:
- A pesar de la COVID-19 y dos CNA, el ensayo EMERGE continuó con éxito el reclutamiento activo y el seguimiento.
- Los desafíos clave incluyeron la escasez de personal, la transición al trabajo remoto y las interrupciones en los sistemas clínicos y de laboratorio.
- Las soluciones implicaron una combinación de herramientas digitales (telemedicina) y métodos tradicionales (registros en papel), junto con una gestión de datos robusta.
Conclusiones:
- Superar desafíos multifacéticos requirió una reorganización rápida, trabajo en equipo y flexibilidad tanto del personal del ensayo como del patrocinador.
- El éxito del ensayo subrayó la importancia de la innovación rápida, la adaptabilidad y la planificación integral del protocolo para gestionar crisis imprevistas.
- La integración de sistemas digitales y basados en papel demostró ser crucial para mantener la continuidad del ensayo y la integridad de los datos.
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