F Bautista1, A Cañete2, G L Ramírez-Villar3, J M Fernández2, J L Fuster4, C Diaz de Heredia5, I Astigarraga6, M García-Ariza6, S Rives7, J L Dapena7, C Márquez3, A Molinés8, M Del M Bermúdez4, S Gallego5, M Del M Andrés2, J Verdu-Amoros9, C Hernández1, M López10, A Catalá7, Á Lassaletta1, O Cruz7, M Ramírez1, F Lendínez11, A Carboné12, J Gomez Sirvent13, M Tallón14, T Acha15, L Moreno16, A Fernández-Teijeiro17. 1. Pediatric Oncology, Hematology and Stem Cell Transplant Department, Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65, 28009, Madrid, Spain. 2. Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Valencia, Spain. 3. Hospital Universitario Virgen del Rocío, Seville, Spain. 4. Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB), Murcia, Spain. 5. Servicio de Onco-Hematología y Transplante, Hospital Universitari Vall d'Hebrón, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain. 6. Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces. Osakidetza. UPV/EHU, Barakaldo, Bizkaia, Spain. 7. Hospital Sant Joan de Déu, Barcelona Institut de Recerca San Joan de Déu, Barcelona, Spain. 8. Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria, Las Palmas, Spain. 9. Hospital Clínico Universitario, Valencia, Spain. 10. Hospital Universitario Marqués de Valdecilla, Santander, Spain. 11. Hospital Universitario Torrecárdenas, Almeria, Spain. 12. Hospital Universitario Miguel Servet, Saragossa, Spain. 13. Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain. 14. Hospital Alvaro Cunqueiro, Vigo, Spain. 15. Hospital Universitario Carlos Haya, Malaga, Spain. 16. Servicio de Onco-Hematología y Transplante, Hospital Universitari Vall d'Hebrón, Passeig de la Vall d'Hebron, 119-129, 08035, Barcelona, Spain. lucas.moreno@vhebron.net. 17. Hospital Universitario Virgen de la Macarena, Seville, Spain.
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.
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.
Entities:
Keywords:
Clinical research; Clinical trials; Drug development; Pediatric hematology and oncology
Authors: F Bautista; S Gallego; A Cañete; J Mora; C Diaz de Heredia; O Cruz; J M Fernández; S Rives; L Madero; V Castel; M E Cela; G Ramírez; C Sábado; T Acha; I Astigarraga; A Sastre; A Muñoz; M Guibelalde; L Moreno Journal: Clin Transl Oncol Date: 2015-10-21 Impact factor: 3.405
Authors: J Galceran; A Ameijide; M Carulla; A Mateos; J R Quirós; D Rojas; A Alemán; A Torrella; M Chico; M Vicente; J M Díaz; N Larrañaga; R Marcos-Gragera; M J Sánchez; J Perucha; P Franch; C Navarro; E Ardanaz; J Bigorra; P Rodrigo; R Peris Bonet Journal: Clin Transl Oncol Date: 2017-01-16 Impact factor: 3.405
Authors: R Marcos-Gragera; J Galceran; C Martos; A L de Munain; M Vicente-Raneda; C Navarro; J R Quirós-Garcia; M-J Sánchez; E Ardanaz; M Ramos; A Mateos; D Salmerón; S Felipe; R Peris-Bonet Journal: Clin Transl Oncol Date: 2016-07-22 Impact factor: 3.405
Authors: C Michel Zwaan; Edward A Kolb; Dirk Reinhardt; Jonas Abrahamsson; Souichi Adachi; Richard Aplenc; Eveline S J M De Bont; Barbara De Moerloose; Michael Dworzak; Brenda E S Gibson; Henrik Hasle; Guy Leverger; Franco Locatelli; Christine Ragu; Raul C Ribeiro; Carmelo Rizzari; Jeffrey E Rubnitz; Owen P Smith; Lillian Sung; Daisuke Tomizawa; Marry M van den Heuvel-Eibrink; Ursula Creutzig; Gertjan J L Kaspers Journal: J Clin Oncol Date: 2015-08-24 Impact factor: 44.544
Authors: Gregory T Armstrong; Yan Chen; Yutaka Yasui; Wendy Leisenring; Todd M Gibson; Ann C Mertens; Marilyn Stovall; Kevin C Oeffinger; Smita Bhatia; Kevin R Krull; Paul C Nathan; Joseph P Neglia; Daniel M Green; Melissa M Hudson; Leslie L Robison Journal: N Engl J Med Date: 2016-01-13 Impact factor: 91.245
Authors: Audrey Bonaventure; Rhea Harewood; Charles A Stiller; Gemma Gatta; Jacqueline Clavel; Daniela C Stefan; Helena Carreira; Devon Spika; Rafael Marcos-Gragera; Rafael Peris-Bonet; Marion Piñeros; Milena Sant; Claudia E Kuehni; Michael F G Murphy; Michel P Coleman; Claudia Allemani Journal: Lancet Haematol Date: 2017-04-11 Impact factor: 18.959