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. 2024 Sep;26(9):2351-2359.
doi: 10.1007/s12094-024-03445-0. Epub 2024 Apr 10.

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

Antonio Juan-Ribelles  1 , Francisco Bautista  2 , Adela Cañete  1 , Alba Rubio-San-Simón  3 , Anna Alonso-Saladrigues  4 , Raquel Hladun  5 , Susana Rives  4 , Jose Luís Dapena  4 , Jose María Fernández  1 , Álvaro Lassaletta  3 , Ofelia Cruz  4 , Gemma Ramírez-Villar  6 , Jose Luís Fuster  7 , Cristina Diaz de Heredia  5 , Miguel García-Ariza  8 , Eduardo Quiroga  6 , María Del Mar Andrés  1 , Jaime Verdú-Amorós  9 , Antonio Molinés  10 , Blanca Herrero  3 , Mónica López  11 , Catalina Márquez  6 , María Toboso  1 , Frencisco Lendínez  12 , Jose Gómez Sirvent  13 , María Tallón  14 , Guiomar Rodríguez  15 , Tomás Acha  16 , Lucas Moreno  17 , Ana Fernández-Teijeiro  18 ; Sociedad Española de Hematología y Oncología Pediátrica (SEHOP)
Affiliations

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

Antonio Juan-Ribelles et al. Clin Transl Oncol. 2024 Sep.

Abstract

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.

Keywords: Clinical research; Clinical trials; Drug development; Metrics; Pediatric hematology and oncology.

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Conflict of interest statement

A. Juan Ribelles has had a consulting/advisory role for Alexion and Bayer, has participated in educational activities organized by Eusa Pharma, Abbott, and Alexion, and has received travel expenses by Nestle and Alexion. F. Bautista has been a member of a data monitoring committee (DMC) in a clinical trial sponsored by Sanofi, had a consulting or advisory role for Bayer, Amgen, Roche Genentech, EusaPharma, and Eisai, and received honoraria from Servier for educational events (through his current affiliation). A. Cañete has had an advisory role for Norgine, Bayer, Roche, Eusa-Pharma, SERB, and participated in educational activities organized by Eusa Pharma and Norgine and received travel expenses from Eusa-pharma and Nestlé. A. Rubio-San Simon has had a advisory role for Eusa Pharma and Sanofi and has received travel expenses by Roche and Eusa Pharma. A. Alonso-Saladrigues (AAS): advisory boards (Novartis). S. Rives reports personal fees, honoraria from Novartis, Servier, Celgene/ Bristol Myers Squibb, Kite/ Gilead, and Amgen. Also reports being part of DMSB in clinical trial sponsored by Novartis and of a DMC in a clinical trial sponsored by Autolus. A. Lassaletta has had an advisory role for Jazz, Servier, and Alexion; has received travel expenses by Servier, and has participated in educational activities organized by Alexion. G. Ramírez-Villar has had an advisory role for Alexion, has received travel expenses by Nestlé and has participated in educational activities organized by Alexion. J.L.Fuster was a consultant/advisory member for Amgen, Jazz Pharmaceuticals, and Novartis, received honoraria from Amgen, Servier, Jazz Pharmaceuticals, Pfizer, and Novartis for speaking at symposia and support from Servier and Jazz Pharmaceuticals for attending symposia. C. Diaz-de-Heredia is a member of study steering committees for clinical trials sponsored by Novartis, had a consulting or advisory role for Novartis, Jazz Pharmaceuticals, Biotest and Vertex, has participated in educational activities organized by Novartis and Jazz Pharmaceuticals and received travel expenses from Jazz Pharmaceuticals and Novartis. J. Verdú-Amorós has received honoraria by Servier and received travel expenses by Servier and EusaPharma. A. Molinés has participated in educational activities organized by Servier receiving travel and accommodation expenses. L. Moreno has been member of data monitoring committees for clinical trials sponsored by Novartis, Actuate Therapeutics, Shionogi and Incyte; had a consulting role for Novartis, Norgine, Boehringer, Ymabs, Bayer, Abbvie, BMS and Shionogi; participated in educational activities organized by Bayer and Eusa Pharma and received travel expenses from Eusa Pharma. He is President Elect of SIOPEN (European neuroblastoma research cooperative group), an organization which receives royalties for the sales of dinutuximab beta. A. Fernández-Teijeiro has had an advisory role for AstraZeneca, SOBI, Takeda, Norgine, Clinigen, Bayer, Roche, MERCK SHARP & DOHME, Novartis and Takeda; participated in educational activities organized by Amgen, Eusa Pharma, Servier and Takeda and received travel expenses from Servier, Amgen and Gilead. The other authors declare no conflict of interest.

Figures

Fig. 1
Fig. 1
ECLIM-SEHOP structured organigram 2023
Fig. 2
Fig. 2
Distribution of ECLIM-SEHOP studies according to cancer type
Fig. 3
Fig. 3
Cumulative patient recruitment in ECLIM-SEHOP clinical trials and observational studies
See this image and copyright information in PMC

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