ECLIM‑SEHOP: : how to develop a platform to conduct academic trials for childhood cancer

• Antonio Juan Ribelles ^[1] ; Adela Cañete ^[1] ; Jose María Fernández ^[1] ; María del Mar Andrés ^[1] ; María Toboso ^[1] ; Francisco Bautista ^[7] ; Alba Rubio San Simón ^[2] ; Álvaro Lassaletta ^[2] ; Blanca Herrero ^[2] ; Anna Alonso Saladrigues ^[8] ; Susana Rives ^[8] ; Jose Luís Dapena ^[8] ; Ofelia Cruz ^[8] ; Raquel Hladun ^[3] ; Cristina Diaz de Heredia ^[3] ; Lucas Moreno ^[3] ; Gemma Ramírez Villar ^[4] ; Eduardo Quiroga ^[4] ; Catalina Márquez ^[4] ; Jose Luís Fuster ^[9] ; Miguel García Ariza ^[10] ; Jaime Verdú Amorós ^[11] ; Antonio Molinés ^[12] ; Mónica López ^[13] ; Francisco Lendínez ^[14] ; Jose Gómez Sirvent ^[15] ; María Tallón ^[5] ; Guiomar Rodríguez ^[16] ; Tomás Acha ^[17] ; Ana Fernández Teijeiro ^[6]
  1. [1] Instituto de Investigación Sanitaria La Fe

     Instituto de Investigación Sanitaria La Fe

     Valencia, España

     
  2. [2] Hospital Infantil Universitario Niño Jesus de Madrid

     Hospital Infantil Universitario Niño Jesus de Madrid

     Madrid, España

     
  3. [3] Hospital Vall d'Hebron

     Hospital Vall d'Hebron

     Barcelona, España

     
  4. [4] Hospital Universitario Virgen del Rocío

     Hospital Universitario Virgen del Rocío

     Sevilla, España

     
  5. [5] Hospital Álvaro Cunqueiro

     Hospital Álvaro Cunqueiro

     Vigo, España

     
  6. [6] Hospital Universitario Virgen Macarena

     Hospital Universitario Virgen Macarena

     Sevilla, España

     
  7. [7] Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands
  8. [8] Pediatric Cancer Center Barcelona (PCCB), Hospital Sant Joan de Déu, Institut de Recerca San Joan de Déu (IRSJD), Barcelona, Spain
  9. [9] Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB), Murcia, Spain
  10. [10] Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces, Osakidetza, Barakaldo, Bizkaia, Spain
  11. [11] INCLIVA - Biomedical Research Institute, Hospital Clínico Universitario, Valencia, Spain
  12. [12] Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria, Las Palmas, Spain
  13. [13] Hematology Department, University Hospital Marqués de Valdecilla (IDIVAL), Santander, Spain
  14. [14] Unidad de Oncohematologia Pediatrica. Hospital Infantil Universitario Torrecárdenas, Almeria, Spain
  15. [15] Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain
  16. [16] Sofpromed, CRO para ensayos clínicos en España, Palma de Mallorca, Spain
  17. [17] Unidad de Oncología Pediátrica, Hospital Materno-Infantil Carlos Haya, Málaga, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 26, Nº. 9, 2024, págs. 2351-2359
• Idioma: inglés
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• Resumen

  • Introduction ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation.

    Methods The platform’s database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted.

    Results ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months.

    Discussion ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.