The paediatric cancer clinical research landscape in Spain: a 13-year multicentre experience of the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)
Por:
Rubio-San-Simón A, Hladun Alvaro R, Juan Ribelles A, Castañeda-Heredia A, Guerra-García P, Verdú-Amorós J, Andrés M, Cañete A, Rives-Solà S, Pérez-Martínez A, Mora J, Patiño-García A, Lassaleta A, Llort A, Ramírez M, Mata C, Gallego S, Martín-Broto J, Cruz-Martínez O, Morales-La Madrid A, Solano P, Martínez Romera I, Fernández-Teijeiro A, Bautista F and Moreno L
Publicada:
1 dic 2021
Ahead of Print:
1 jun 2021
Resumen:
Purpose Early phase trials are crucial in developing innovative effective agents for childhood malignancies. We report the activity in early phase paediatric oncology trials in Spain from its beginning to the present time and incorporate longitudinal data to evaluate the trends in trial characteristics and recruitment rates. Methods Members of SEHOP were contacted to obtain information about the open trials at their institutions. The study period was split into two equal periods for analysis: 2007-2013 and 2014-2020. Results Eighty-one trials and two molecular platforms have been initiated. The number of trials has increased over the time of the study for all tumour types, with a predominance of trials available for solid tumours (66%). The number of trials addressed to tumours harbouring specific molecular alterations has doubled during the second period. The proportion of industry-sponsored compared to academic trials has increased over the same years. A total of 565 children and adolescents were included, with an increasing trend over the study period. For international trials, the median time between the first country study approval and the Spanish competent authority approval was 2 months (IQR 0-6.5). Fourteen out of 81 trials were sponsored by Spanish academic institutions. Conclusions The number of available trials, and the number of participating patients, has increased in Spain from 2007. Studies focused on molecular-specific targets are now being implemented. Barriers to accessing new drugs for all ranges of age and cancer diseases remain. Additionally, opportunities to improve academic research are still required in Spain.
Filiaciones:
Rubio-San-Simón A:
Paediatric Oncology-Haematology Department, Hospital Universitario Niño Jesús, Madrid, Spain
Hladun Alvaro R:
Paediatric Oncology-Haematology Department, Hospital Universitario Vall D'Hebrón, Barcelona, Spain
Juan Ribelles A:
Paediatric Oncology-Haematology Department, Hospital Universitario Y Politécnico de La Fe, Valencia, Spain
Castañeda-Heredia A:
Paediatric Oncology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Guerra-García P:
Paediatric Oncology-Haematology Department, Hospital La Paz Institute for Health Research-IdiPAZ, Madrid, Spain
Verdú-Amorós J:
Paediatric Oncology-Haematology Department, Hospital Clínico Universitario, Valencia, Spain
Andrés M:
Paediatric Oncology-Haematology Department, Hospital Universitario Y Politécnico de La Fe, Valencia, Spain
Cañete A:
Paediatric Oncology-Haematology Department, Hospital Universitario Y Politécnico de La Fe, Valencia, Spain
Rives-Solà S:
Paediatric Oncology-Haematology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Pérez-Martínez A:
Paediatric Oncology-Haematology Department, Hospital La Paz, Madrid, Spain
Mora J:
Paediatric Oncology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Patiño-García A:
Paediatric Oncology-Haematology Department, Clínica Universidad de Navarra, Pamplona, Spain
Lassaleta A:
Paediatric Oncology-Haematology Department, Hospital Universitario Niño Jesús, Madrid, Spain
Llort A:
Paediatric Oncology-Haematology Department, Hospital Universitario Vall D'Hebrón, Barcelona, Spain
Ramírez M:
Paediatric Oncology-Haematology Department, Hospital Universitario Niño Jesús, Madrid, Spain
Mata C:
Paediatric Oncology-Haematology Department, Hospital Gregorio Marañón, Madrid, Spain
Gallego S:
Paediatric Oncology-Haematology Department, Hospital Universitario Vall D'Hebrón, Barcelona, Spain
Martín-Broto J:
Medical Oncology Department, Fundación Jiménez Díaz, Madrid, Spain
Cruz-Martínez O:
Paediatric Oncology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Morales-La Madrid A:
Paediatric Oncology Department, Hospital Sant Joan de Déu, Barcelona, Spain
Solano P:
Paediatric Oncology-Haematology Department, Hospital Universitario Virgen del Rocio, Seville, Spain
Martínez Romera I:
Paediatric Oncology-Haematology Department, Hospital La Paz, Madrid, Spain
Fernández-Teijeiro A:
Paediatric Oncology-Haematology Unit, Hospital Universitario Virgen Macarena, Seville, Spain
Bautista F:
Paediatric Oncology-Haematology Department, Hospital Universitario Niño Jesús, Madrid, Spain.
Paediatric Oncology, Haematology and Haematopoietic Stem Cell Transplant Department, Hospital Universitario Niño Jesús, Avenida Menéndez Pelayo, 65, 28009, Madrid, Spain.
Moreno L:
Paediatric Oncology-Haematology Department, Hospital Universitario Vall D'Hebrón, Barcelona, Spain
Open Access
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