Pediatric Oncology and Hematology Unit, Hospital Universitari y Politécnic La Fe, Instituto de Investigación Sanitaria La Fe (IISLAFE), Valencia, Spain.
Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
Clin Transl Oncol. 2024 Sep;26(9):2351-2359. doi: 10.1007/s12094-024-03445-0. Epub 2024 Apr 10.
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.
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.
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.
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 平台创建于 2017 年。其主要目标是建立基础设施，允许西班牙参与国际学术合作的临床试验、观察性研究和儿科肿瘤学注册研究。本文旨在描述 ECLIM-SEHOP 自成立以来开展的活动。
查询平台数据库，提供该组织全面和部分支持的研究概述。提取自成立以来至 2023 年 11 月的试验招募和设置/实施指标数据。
ECLIM-SEHOP 支持了 47 项研究：29 项临床试验和 18 项观察性研究/注册研究，共招募了 5250 名患者。该组织提供了 25 项研究的全面支持：16 项招募 584 名患者的临床试验和 9 项招募 278 名患者的观察性研究/注册研究。这些试验包括白血病、淋巴瘤、脑和实体颅外肿瘤的一线研究，以及其他关键的横向课题，如靶向治疗的标签外使用和生存。从监管机构提交到第一个患者入组的平均时间为 12.2 个月，从第一个国际站点开放到第一个西班牙站点开放的平均时间为 31.3 个月。
ECLIM-SEHOP 平台极大地提高了国际学术临床试验的可及性和可获得性，并促进了儿童癌症治疗资源的集中化。尽管临床试验设置指标的进展显著，但时间仍需进一步改善。该项目有助于提高西班牙与其他欧洲国家的生存率，过去这些国家的生存率存在较大差异。
