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)

Rubio-San-Simón A; Hladun Alvaro R; Juan Ribelles A; Castañeda Heredia A; Guerra-García P; Verdú-Amorós J; Andrés M; Cañete A; Rives S; Pérez-Martínez A; Mora J; Patiño-García A; Lassaleta A; Llort A; Ramírez M; Mata C; Gallego S; Martín-Broto J; Cruz O; Morales La Madrid A; Solano P; Martínez Romera I; Fernández-Teijeiro A; Bautista F; Moreno L

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)

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 characterist...

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Autores:	Rubio-San-Simón A, Hladun Alvaro R, Juan Ribelles A, Castañeda Heredia A, Guerra-García P, Verdú-Amorós J, Andrés M, Cañete A, Rives S, Pérez-Martínez A, Mora J, Patiño-García A, Lassaleta A, Llort A, Ramírez M, Mata C, Gallego S, Martín-Broto J, Cruz O, Morales La Madrid A, Solano P, Martínez Romera I, Fernández-Teijeiro A, Bautista F, Moreno L
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2021
País:	España
Institución:	Fundació Sant Joan de Déu
Repositorio:	r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:	oai:fsjd.fundanetsuite.com:p19674
Acceso en línea:	https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=19674
Access Level:	acceso abierto
Palabra clave:	Paediatric haematology and oncology Clinical trials Drug development Clinical research Access to innovation

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spelling	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)Rubio-San-Simón AHladun Alvaro RJuan Ribelles ACastañeda Heredia AGuerra-García PVerdú-Amorós JAndrés MCañete ARives SPérez-Martínez AMora JPatiño-García ALassaleta ALlort ARamírez MMata CGallego SMartín-Broto JCruz OMorales La Madrid ASolano PMartínez Romera IFernández-Teijeiro ABautista FMoreno LPaediatric haematology and oncologyClinical trialsDrug developmentClinical researchAccess to innovationPurpose 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.SPRINGER INT PUBL AG2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=19674Clinical & Translational OncologyISSN: 1699048XISSNe: 16993055reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p196742026-05-27T12:37:41Z
dc.title.none.fl_str_mv	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)
title	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)
spellingShingle	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) Rubio-San-Simón A Paediatric haematology and oncology Clinical trials Drug development Clinical research Access to innovation
title_short	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)
title_full	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)
title_fullStr	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)
title_full_unstemmed	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)
title_sort	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)
dc.creator.none.fl_str_mv	Rubio-San-Simón A Hladun Alvaro R Juan Ribelles A Castañeda Heredia A Guerra-García P Verdú-Amorós J Andrés M Cañete A Rives S Pérez-Martínez A Mora J Patiño-García A Lassaleta A Llort A Ramírez M Mata C Gallego S Martín-Broto J Cruz O Morales La Madrid A Solano P Martínez Romera I Fernández-Teijeiro A Bautista F Moreno L
author	Rubio-San-Simón A
author_facet	Rubio-San-Simón A Hladun Alvaro R Juan Ribelles A Castañeda Heredia A Guerra-García P Verdú-Amorós J Andrés M Cañete A Rives S Pérez-Martínez A Mora J Patiño-García A Lassaleta A Llort A Ramírez M Mata C Gallego S Martín-Broto J Cruz O Morales La Madrid A Solano P Martínez Romera I Fernández-Teijeiro A Bautista F Moreno L
author_role	author
author2	Hladun Alvaro R Juan Ribelles A Castañeda Heredia A Guerra-García P Verdú-Amorós J Andrés M Cañete A Rives S Pérez-Martínez A Mora J Patiño-García A Lassaleta A Llort A Ramírez M Mata C Gallego S Martín-Broto J Cruz O Morales La Madrid A Solano P Martínez Romera I Fernández-Teijeiro A Bautista F Moreno L
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Paediatric haematology and oncology Clinical trials Drug development Clinical research Access to innovation
topic	Paediatric haematology and oncology Clinical trials Drug development Clinical research Access to innovation
description	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.
publishDate	2021
dc.date.none.fl_str_mv	2021
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=19674
url	https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=19674
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	SPRINGER INT PUBL AG
publisher.none.fl_str_mv	SPRINGER INT PUBL AG
dc.source.none.fl_str_mv	Clinical & Translational Oncology ISSN: 1699048X ISSNe: 16993055 reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu instname:Fundació Sant Joan de Déu
instname_str	Fundació Sant Joan de Déu
reponame_str	r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection	r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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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)

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