ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain

• F. Bautista ^[1] ; A. Cañete ^[10] ; G. L. Ramírez-Villar ^[2] ; J. M. Fernández ^[10] ; J. L. Fuster ^[11] ; C. Diaz de Heredia ^[3] ; I. Astigarraga ^[4] ; M. García-Ariza ^[4] ; S. Rives ^[5] ; J. L. Dapena ^[5] ; C. Márquez ^[2] ; A. Molinés ^[6] ; M. del M. Bermúdez ^[11] ; S. Gallego ^[3] ; M. del M. Andrés ^[10] ; J. Verdu-Amoros ^[12] ; C. Hernández ^[1] ; M. López ^[7] ; A. Catalá ^[5] ; Á. Lassaletta ^[1] ; O. Cruz ^[5] ; M. Ramírez ^[1] ; F. Lendínez ^[13] ; A. Carboné ^[8] ; J. Gomez Sirvent ^[14] ; M. Tallón ^[9] ; T. Acha ^[15] ; L. Moreno ^[3] ; A. Fernández-Teijeiro ^[16] ; Sociedad Española de Hematología y Oncología Pediátrica
  1. [1] Hospital Infantil Universitario Niño Jesus de Madrid

     Hospital Infantil Universitario Niño Jesus de Madrid

     Madrid, España

     
  2. [2] Hospital Universitario Virgen del Rocío

     Hospital Universitario Virgen del Rocío

     Sevilla, España

     
  3. [3] Hospital Vall d'Hebron

     Hospital Vall d'Hebron

     Barcelona, España

     
  4. [4] Instituto de Investigación Sanitaria Biocruces Bizkaia

     Instituto de Investigación Sanitaria Biocruces Bizkaia

     Barakaldo, España

     
  5. [5] Hospital Sant Joan de Deu

     Hospital Sant Joan de Deu

     Barcelona, España

     
  6. [6] Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

     Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

     Gran Canaria, España

     
  7. [7] Hospital Universitario Marqués de Valdecilla

     Hospital Universitario Marqués de Valdecilla

     Santander, España

     
  8. [8] Hospital Miguel Servet

     Hospital Miguel Servet

     Zaragoza, España

     
  9. [9] Hospital Álvaro Cunqueiro

     Hospital Álvaro Cunqueiro

     Vigo, España

     
  10. [10] Hospital Universitario y Politécnico La Fe
  11. [11] Hospital Universitario Virgen de la Arrixaca,
  12. [12] Hospital Clínico Universitario Valencia
  13. [13] Hospital Universitario Torrecárdenas
  14. [14] Hospital Universitario Nuestra Señora de la Candelaria
  15. [15] Hospital Universitario Carlos Haya
  16. [16] Hospital Universitario Virgen de la Macarena

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 21, Nº. 12 (December), 2019, págs. 1763-1770
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Dialnet Métricas: 1 Cita
• Resumen

  • Introduction Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufficient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of financial support and limited research infrastructure in our hospitals.

    Methods The objective of ECLIM-SEHOP platform (Ensayos Clínicos Internacionales Multicéntricos-SEHOP) is to overcome these difficulties and position Spain among the European countries leading the advances in cancer and blood disorders, facilitate the access of our patients to novel diagnostic and therapeutic approaches and, most importantly, continue to improve survival and reducing long-term sequelae. ECLIM-SEHOP provides to the Spanish clinical investigators with the necessary infrastructural support to open and implement academic clinical trials and registries.

    Results In less than 3 years from its inception, the platform has provided support to 20 clinical trials and 8 observational studies, including 8 trials and 4 observational studies where the platform performs all trial-related tasks (integral support: trial setup, monitoring, etc.) with more than 150 patients recruited since 2017 to these studies. In this manuscript, we provide baseline metrics for academic clinical trial performance that permit future comparisons.

    Conclusions ECLIM-SEHOP facilitates Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies.