title: [Early clinical trials in paediatric oncology in Spain: a nationwide perspective].
abstract: BACKGROUND
  Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice. A report is presented on the activity in early paediatric oncology trials (phase I-II) in Spain.
  
  
  METHODS
  All members of the Spanish Society of Paediatric Haematology Oncology (SEHOP) were contacted in order to identify early clinical trials in paediatric cancer opened between 2005 and 2015.
  
  
  RESULTS
  A total of 30 trials had been opened in this period: 21 (70%) in solid tumours, and 9 (30%) in malignant haemopathies. A total of 212 patients have been enrolled. The majority was industry sponsored (53%). Since 2010, four centres have joined the international consortium of Innovative Therapies for Children with Cancer (ITCC), which has as its aim to develop novel therapies for paediatric tumours. A significant number of new studies have opened since 2010, improving the treatment opportunities for our children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents, and their benefits.
  
  
  CONCLUSIONS
  The activity in clinical trials has increased in the years analysed. The SEHOP is committed to develop and participate in collaborative academic trials, in order to help in the advancement and optimisation of existing therapies in paediatric cancer.
authors.affiliation: Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España. Electronic address: fjbautisir@gmail.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Bautista
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: Soledad
authors.initials: S
authors.lastname: Gallego
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario y Politécnico La Fe, Valencia, España.
authors.forename: Adela
authors.initials: A
authors.lastname: Cañete
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Sant Joan de Déu, Barcelona, España.
authors.forename: Jaume
authors.initials: J
authors.lastname: Mora
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: Cristina
authors.initials: C
authors.lastname: Díaz de Heredia
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Sant Joan de Déu, Barcelona, España.
authors.forename: Ofelia
authors.initials: O
authors.lastname: Cruz
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario y Politécnico La Fe, Valencia, España.
authors.forename: José María
authors.initials: JM
authors.lastname: Fernández
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Sant Joan de Déu, Barcelona, España.
authors.forename: Susana
authors.initials: S
authors.lastname: Rives
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario y Politécnico La Fe, Valencia, España.
authors.forename: Pablo
authors.initials: P
authors.lastname: Berlanga
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: Raquel
authors.initials: R
authors.lastname: Hladun
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario y Politécnico La Fe, Valencia, España.
authors.forename: Antonio
authors.initials: A
authors.lastname: Juan Ribelles
authors.affiliation: Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España.
authors.forename: Luis
authors.initials: L
authors.lastname: Madero
authors.affiliation: Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España.
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramírez
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Clínico, Valencia, España.
authors.forename: Rafael
authors.initials: R
authors.lastname: Fernández Delgado
authors.affiliation: Unidad de Oncología Pediátrica, Hospital La Paz, Madrid, España.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pérez-Martínez
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Gregorio Marañón, Madrid, España.
authors.forename: Cristina
authors.initials: C
authors.lastname: Mata
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: Anna
authors.initials: A
authors.lastname: Llort
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Virgen del Rocío, Sevilla, España.
authors.forename: Javier
authors.initials: J
authors.lastname: Martín Broto
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Gregorio Marañón, Madrid, España.
authors.forename: María Elena
authors.initials: ME
authors.lastname: Cela
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Virgen del Rocío, Sevilla, España.
authors.forename: Gema
authors.initials: G
authors.lastname: Ramírez
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
authors.forename: Constantino
authors.initials: C
authors.lastname: Sábado
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Carlos Haya, Málaga, España.
authors.forename: Tomás
authors.initials: T
authors.lastname: Acha
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario Cruces, Barakaldo, IIS BioCruces, Universidad del País Vasco (UPV/EHU), España.
authors.forename: Itziar
authors.initials: I
authors.lastname: Astigarraga
authors.affiliation: Unidad de Oncología Pediátrica, Hospital La Paz, Madrid, España.
authors.forename: Ana
authors.initials: A
authors.lastname: Sastre
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Miguel Servet, Zaragoza, España.
authors.forename: Ascensión
authors.initials: A
authors.lastname: Muñoz
authors.affiliation: Unidad de Oncología Pediátrica, Hospital Universitario Son Espases, Palma de Mallorca, España.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Guibelalde
authors.affiliation: Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España; Instituto de Investigación La Princesa, Madrid, España.
authors.forename: Lucas
authors.initials: L
authors.lastname: Moreno
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D013030:Spain; D013997:Time Factors
keywords: Desarrollo de nuevos fármacos; Drug development; Early phase clinical trials; Ensayos clínicos precoces; Medicina personalizada; Oncología y hematología pediátrica; Paediatric haematology and oncology; Personalised medicine