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. 2019 Dec;21(12):1763-1770.
doi: 10.1007/s12094-019-02221-9. Epub 2019 Oct 9.

ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain

F Bautista  1 , A Cañete  2 , G L Ramírez-Villar  3 , J M Fernández  2 , J L Fuster  4 , C Diaz de Heredia  5 , I Astigarraga  6 , M García-Ariza  6 , S Rives  7 , J L Dapena  7 , C Márquez  3 , A Molinés  8 , M Del M Bermúdez  4 , S Gallego  5 , M Del M Andrés  2 , J Verdu-Amoros  9 , C Hernández  1 , M López  10 , A Catalá  7 , Á Lassaletta  1 , O Cruz  7 , M Ramírez  1 , F Lendínez  11 , A Carboné  12 , J Gomez Sirvent  13 , M Tallón  14 , T Acha  15 , L Moreno  16 , A Fernández-Teijeiro  17 ; Sociedad Española de Hematología y Oncología Pediátrica (SEHOP)
Affiliations
Free article

ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain

F Bautista et al. Clin Transl Oncol. 2019 Dec.
Free article

Abstract

Introduction: Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufficient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of financial support and limited research infrastructure in our hospitals.

Methods: The objective of ECLIM-SEHOP platform (Ensayos Clínicos Internacionales Multicéntricos-SEHOP) is to overcome these difficulties and position Spain among the European countries leading the advances in cancer and blood disorders, facilitate the access of our patients to novel diagnostic and therapeutic approaches and, most importantly, continue to improve survival and reducing long-term sequelae. ECLIM-SEHOP provides to the Spanish clinical investigators with the necessary infrastructural support to open and implement academic clinical trials and registries.

Results: In less than 3 years from its inception, the platform has provided support to 20 clinical trials and 8 observational studies, including 8 trials and 4 observational studies where the platform performs all trial-related tasks (integral support: trial setup, monitoring, etc.) with more than 150 patients recruited since 2017 to these studies. In this manuscript, we provide baseline metrics for academic clinical trial performance that permit future comparisons.

Conclusions: ECLIM-SEHOP facilitates Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies.

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

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References

    1. Arch Dis Child. 2018 Jun;103(6):557-564 - PubMed
    1. Lancet Oncol. 2013 Mar;14(3):189-91 - PubMed
    1. Lancet Haematol. 2017 May;4(5):e202-e217 - PubMed
    1. Eur J Cancer. 2016 Jul;61:11-9 - PubMed
    1. Clin Transl Oncol. 2016 Jul;18(7):708-13 - PubMed

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