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

Abstract

Desarrollo de fármacos; Ensayos clínicos; Hematología y oncología pediátrica

Drug development; Clinical trials; Pediatric hematology and oncology

Desenvolupament de fàrmacs; Assaigs clínics; Hematologia i oncologia pediàtrica

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.

ECLIM-SEHOP was supported by the grant “Cáncer infantil y cánceres poco frecuentes 2018” from Asociación Española Contra el Cáncer (AECC) (Grant CICPF18016FERN 2018). Support is also received from Federación Española de Padres de Niños con Cáncer, Asociación Pablo Ugarte, Fundación Inocente, ACAYE, Uno entre cien mil and Fundación MAR.