Literature DB >> 31598904

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

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.   

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.

Entities:  

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

Mesh:

Year:  2019        PMID: 31598904     DOI: 10.1007/s12094-019-02221-9

Source DB:  PubMed          Journal:  Clin Transl Oncol        ISSN: 1699-048X            Impact factor:   3.405


  11 in total

1.  Children with cancer: driving the global agenda.

Authors:  Kathy Pritchard-Jones; Richard Sullivan
Journal:  Lancet Oncol       Date:  2013-02-20       Impact factor: 41.316

2.  Landscape of early clinical trials for childhood and adolescence cancer in Spain.

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

3.  Cancer incidence in Spain, 2015.

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

4.  More medicines for children: impact of the EU paediatric regulation.

Authors:  Sofia Nordenmalm; Paolo Tomasi; Chrissi Pallidis
Journal:  Arch Dis Child       Date:  2018-02-28       Impact factor: 3.791

5.  Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5--a population-based study.

Authors:  Gemma Gatta; Laura Botta; Silvia Rossi; Tiiu Aareleid; Magdalena Bielska-Lasota; Jacqueline Clavel; Nadya Dimitrova; Zsuzsanna Jakab; Peter Kaatsch; Brigitte Lacour; Sandra Mallone; Rafael Marcos-Gragera; Pamela Minicozzi; Maria-José Sánchez-Pérez; Milena Sant; Mariano Santaquilani; Charles Stiller; Andrea Tavilla; Annalisa Trama; Otto Visser; Rafael Peris-Bonet
Journal:  Lancet Oncol       Date:  2013-12-05       Impact factor: 41.316

6.  Incidence and survival time trends for Spanish children and adolescents with leukaemia from 1983 to 2007.

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

7.  European Survey on Standards of Care in paediatric oncology centres.

Authors:  Jerzy R Kowalczyk; Marzena Samardakiewicz; Kathy Pritchard-Jones; Ruth Ladenstein; Samira Essiaf; Edel Fitzgerald; Giulia Petrarulo; Gilles Vassal
Journal:  Eur J Cancer       Date:  2016-04-28       Impact factor: 9.162

Review 8.  Collaborative Efforts Driving Progress in Pediatric Acute Myeloid Leukemia.

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

9.  Reduction in Late Mortality among 5-Year Survivors of Childhood Cancer.

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

10.  Worldwide comparison of survival from childhood leukaemia for 1995-2009, by subtype, age, and sex (CONCORD-2): a population-based study of individual data for 89 828 children from 198 registries in 53 countries.

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

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