[Early clinical trials in paediatric oncology in Spain: a nationwide perspective]

Francisco Bautista1, Soledad Gallego2, Adela Cañete3

  • 1Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España.

Abstract

Insights

Early phase clinical trials for paediatric cancers in Spain have increased since 2010, offering new treatment opportunities. This includes novel targeted therapies and immunotherapies, improving outcomes for children with malignant haemopathies and solid tumours.

Area of Science:

  • Paediatric Oncology
  • Clinical Trial Research
  • Cancer Therapeutics

Background:

  • Cancer remains a leading cause of death in children and adolescents, necessitating novel therapeutic strategies.
  • Translating adult cancer drug development advancements to paediatric settings is crucial.
  • Early-phase clinical trials are vital for introducing new anti-cancer drugs in children.

Purpose of the Study:

  • To report on the activity and trends in early-phase (I-II) paediatric oncology clinical trials in Spain between 2005 and 2015.
  • To assess the landscape of paediatric cancer research and treatment development in Spain.

Main Methods:

  • A survey was conducted among members of the Spanish Society of Paediatric Haematology Oncology (SEHOP).
  • Data collected focused on early clinical trials initiated in Spain from 2005 to 2015.

Main Results:

  • Thirty early-phase clinical trials were identified, with 70% focusing on solid tumours and 30% on malignant haemopathies.
  • A total of 212 patients were enrolled, with 53% of trials being industry-sponsored.
  • Since 2010, increased trial activity and participation in international consortia like ITCC have been observed, introducing molecularly targeted agents.

Conclusions:

  • Paediatric oncology clinical trial activity in Spain has significantly increased.
  • Collaborative academic trials are essential for advancing and optimizing paediatric cancer therapies.
  • Spanish investigators are contributing to the development and benefits of novel anti-cancer agents for children.

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