ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer
Por:
Juan-Ribelles A, Bautista F, Cañete A, Rubio-San-Simón A, Alonso-Saladrigues A, Hladun R, Rives S, Dapena J, Fernández J, Lassaletta A, Cruz O, Ramírez-Villar G, Fuster J, de Heredia C, García-Ariza M, Quiroga E, Andrés M, Verdú-Amorós J, Molinés A, Herrero B, López M, Márquez C, Toboso M, Lendínez F, Sirvent J, Tallón M, Rodríguez G, Acha T, Moreno L, Fernández-Teijeiro A
Publicada:
1 sep 2024
Ahead of Print:
1 abr 2024
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.
Filiaciones:
Juan-Ribelles A:
Hosp Univ & Politecn La Fe, Pediat Oncol & Hematol Unit, Inst Invest Sanitaria La Fe IISLAFE, Valencia, Spain
Bautista F:
Princess Maxima Ctr Pediat Oncol, Utrecht, Netherlands
Cañete A:
Hosp Univ & Politecn La Fe, Pediat Oncol & Hematol Unit, Inst Invest Sanitaria La Fe IISLAFE, Valencia, Spain
Rubio-San-Simón A:
Hosp Infantil Univ Nino Jesus, Hematol & Stem Cell Transplant Dept, Pediat Oncol, Madrid, Spain
Alonso-Saladrigues A:
Hosp St Joan Deu, Inst Recerca San Joan Deu IRSJD, Pediat Canc Ctr Barcelona PCCB, Barcelona, Spain
Hladun R:
Hosp Univ Vall dHebron, Vall dHebron Comprehens Canc Ctr, Div Pediat Hematol & Oncol, Passeig Vall dHebron 119, Barcelona 08172, Spain
Rives S:
Hosp St Joan Deu, Inst Recerca San Joan Deu IRSJD, Pediat Canc Ctr Barcelona PCCB, Barcelona, Spain
Dapena J:
Hosp St Joan Deu, Inst Recerca San Joan Deu IRSJD, Pediat Canc Ctr Barcelona PCCB, Barcelona, Spain
Fernández J:
Hosp Univ & Politecn La Fe, Pediat Oncol & Hematol Unit, Inst Invest Sanitaria La Fe IISLAFE, Valencia, Spain
Lassaletta A:
Hosp Infantil Univ Nino Jesus, Hematol & Stem Cell Transplant Dept, Pediat Oncol, Madrid, Spain
Cruz O:
Hosp St Joan Deu, Inst Recerca San Joan Deu IRSJD, Pediat Canc Ctr Barcelona PCCB, Barcelona, Spain
Ramírez-Villar G:
Hosp Univ Virgen Rocio, Dept Pediat Oncol, Seville, Spain
Fuster J:
Hosp Univ Virgen Arrixaca, Inst Murciano Invest Biosanitaria IMIB, Murcia, Spain
de Heredia C:
Hosp Univ Vall dHebron, Vall dHebron Comprehens Canc Ctr, Div Pediat Hematol & Oncol, Passeig Vall dHebron 119, Barcelona 08172, Spain
García-Ariza M:
Hosp Univ Cruces, Biocruces Bizkaia Hlth Res Inst, Baracaldo, Bizkaia, Spain
Quiroga E:
Hosp Univ Virgen Rocio, Dept Pediat Oncol, Seville, Spain
Andrés M:
Hosp Univ & Politecn La Fe, Pediat Oncol & Hematol Unit, Inst Invest Sanitaria La Fe IISLAFE, Valencia, Spain
Verdú-Amorós J:
Hosp Clin Univ, Biomed Res Inst, INCLIVA, Valencia, Spain
Molinés A:
Complejo Hosp Univ Insular Materno Infanti, Las Palmas Gran Canaria, Las Palmas, Spain
Herrero B:
Hosp Infantil Univ Nino Jesus, Hematol & Stem Cell Transplant Dept, Pediat Oncol, Madrid, Spain
López M:
Univ Hosp Marques Valdecilla IDIVAL, Hematol Dept, Santander, Spain
Márquez C:
Hosp Univ Virgen Rocio, Dept Pediat Oncol, Seville, Spain
Toboso M:
Hosp Univ & Politecn La Fe, Pediat Oncol & Hematol Unit, Inst Invest Sanitaria La Fe IISLAFE, Valencia, Spain
Lendínez F:
Hosp Infantil Univ Torrecardenas, Un Oncohematol Pediat, Almeria, Spain
Sirvent J:
Hosp Univ Nuestra Senora Candelaria, Santa Cruz De Tenerife, Spain
Tallón M:
Hosp Alvaro Cunqueiro, Vigo, Spain
Rodríguez G:
Sofpromed, CRO ensayos Clin Espana, Palma De Mallorca, Spain
Acha T:
Hosp Materno Infantil Carlos Haya, Un Oncol Pediat, Malaga, Spain
Moreno L:
Hosp Univ Vall dHebron, Vall dHebron Comprehens Canc Ctr, Div Pediat Hematol & Oncol, Passeig Vall dHebron 119, Barcelona 08172, Spain
Fernández-Teijeiro A:
Hosp Univ Virgen Macarena, Seville, Spain
Green Submitted, hybrid
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