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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)



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.


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.


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.


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.

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  1. Pardo Romaguera E, Muñoz López A, Valero Poveda S, Porta Cebolla S, CañeteNieto A, Barreda Reines MS, Peris Bonet R. Cáncer infantil en España. Estadísticas 1980–2019. Registro Español de Tumores Infantiles (RETI-SEHOP). Ministerio de Sanidad, Servicios Sociales e Igualdad. 2019. p. 1–58

  2. Kowalczyk JR, Samardakiewicz M, Pritchard-Jones K, Ladenstein R, Essiaf S, Fitzgerald E, et al. European survey on standards of care in paediatric oncology centres. Eur J Cancer. 2016;61:11–9.

    Article  Google Scholar 

  3. Skinner R, Wallace WHB, Levitt GA. Long-term follow-up of people who have survived cancer during childhood. Lancet Oncol. 2006;7:489–98.

    Article  Google Scholar 

  4. Hjorth L, Haupt R, Skinner R, Grabow D, Byrne J, Karner S, et al. Survivorship after childhood cancer: PanCare: a European network to promote optimal long-term care. Eur J Cancer. 2015;51(10):1203–11.

    Article  Google Scholar 

  5. European Medicines Agency|[Internet]. Cited 11 Apr 2021

  6. Kearns PR, Vassal G, Ladenstein R, Schrappe M, Biondi A, Blanc P, et al. A European paediatric cancer mission: aspiration or reality? Lancet Oncol. 2019;20:1200–2.

    Article  Google Scholar 

  7. Accelerate Platform. Cancer in children and adolescents—accelerate platform. Cited 3 Apr 2021

  8. Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV. New drug approvals in oncology. Nat Rev Clin Oncol. 2020;17:140–6.

    Article  Google Scholar 

  9. Vitrakvi|European Medicines Agency. Cited 13 Dec 2020

  10. Rozlytrek|European Medicines Agency. Cited 13 Dec 2020

  11. Pearson ADJ, Herold R, Rousseau R, Copland C, Bradley-Garelik B, Binner D, et al. Implementation of mechanism of action biology-driven early drug development for children with cancer. Eur J Cancer. 2016;62:124–31.

    Article  Google Scholar 

  12. Neel DV, Shulman DS, DuBois SG. Timing of first-in-child trials of FDA-approved oncology drugs. Eur J Cancer. 2019;112:49–56.

    Article  Google Scholar 

  13. European Parliament and the Council. Regulation (EC) No 1901/2006 of the European Parliament and of the council on medicinal products for paediatric use. Off J Eur Union. 2006.

  14. Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos. [Internet]. BOLETÍN OFICIAL DEL ESTADO. Cited 13 Dec 2020

  15. Zwaan CM, Kearns P, Caron H, Verschuur A, Riccardi R, Boos J, et al. The role of the “innovative therapies for children with cancer” (ITCC) European consortium. Cancer Treat Rev. 2010;36:328–34.

    Article  Google Scholar 

  16. Bautista F, Cañete A, Ramírezillar GL, Fernández JM, Fuster JL, Diaz de Heredia C, et al. ECLIM-SEHOP a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain. Clin Transl Oncol. 2019;21(12):1763–70.

    CAS  Article  Google Scholar 

  17. Bautista F, Gallego S, Cañete A, Mora J, Diazde Heredia C, Cruz O, et al. Landscape of early clinical trials for childhood and adolescence cancer in Spain. Clin Transl Oncol. 2016;18(7):708–13.

    CAS  Article  Google Scholar 

  18. farmaindustria. La industria farmacéutica ha duplicado su inversión en investigación clínica en España desde 2005—FarmaIndustria. Cited 27 Dec 2020

  19. Nordenmalm S, Tomasi P, Pallidis C. More medicines for children: impact of the EU paediatric regulation. Arch Dis Child. 2018;103(6):557–64.

    Article  Google Scholar 

  20. Vassal G, Rousseau R, Blanc P, Moreno L, Bode G, Schwoch S, et al. Creating a unique, multi-stakeholder paediatric oncology platform to improve drug development for children and adolescents with cancer. Eur J Cancer. 2015;51(2):218–24.

    Article  Google Scholar 

  21. Roper N, Stensland KD, Hendricks R, Galsky MD. The landscape of precision cancer medicine clinical trials in the United States. Cancer Treat Rev. 2015;41:385–90.

    Article  Google Scholar 

  22. Dietel M, Jöhrens K, Laffert MV, Hummel M, Bläker H, Pfitzner BM, et al. Update on predictive molecular pathology and its role in targeted cancer therapy: a review focussing on clinical relevance. Cancer Gene Ther. 2015;22:417–30.

    CAS  Article  Google Scholar 

  23. Morgenstern DA, Hargrave D, Marshall LV, Gatz SA, Barone G, Crowe T, et al. Toxicity and outcome of children and adolescents participating in phase I/II trials of novel anticancer drugs: the royal marsden experience. J Pediatr Hematol Oncol. 2014;36(3):218–23.

    CAS  Article  Google Scholar 

  24. De Rojas T, Neven A, Terada M, Garcia-Abos M, Moreno L, Gaspar N, et al. Access to clinical trials for adolescents and young adults with cancer: a meta-research analysis. JNCI Cancer Spectr. 2019;3(4):pkz057.

    Article  Google Scholar 

  25. Desandes E, Stark DP. Epidemiology of adolescents and young adults with cancer in Europe. Prog Tumor Res. 2016;43:1–15.

    Article  Google Scholar 

  26. Medicamentos Innovadores Proyecto BEST. Cited 27 Mar 2021

  27. Farmaindustria. Ranking de España resto países, Datos y Análisis 19a Publicación BD Metrics, Informe del Proyecto BEST, Pág. 133. Datos y Análisis 19a Publicación BD Metrics. 2016.

  28. Osborne JP, O’Callaghan FJK. Running an international paediatric non-commercial clinical trial. Arch Dis Child. 2009;94:729–33.

    CAS  Article  Google Scholar 

  29. Demotes-Mainard J, Ohmann C. European clinical research infrastructures network: promoting harmonisation and quality in European clinical research. Lancet. 2005;365:107–8.

    Article  Google Scholar 

  30. Horizon 2020|The EU Framework Programme for Research and Innovation. Cited 27 Dec 2020

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Authors and Affiliations



All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by AR-S-S and FB. The first draft of the manuscript was written by AR-S-S and FB and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to F. Bautista.

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Conflict of interest

R. Hladun had an advisory role for Roche, and she received honoraria from EusaPharma for an educational event. A. Cañete had a consulting or advisory role for EusaPharma and Bayer. She received honoraria from EusaPharma for educational events and travel expenses. A Cañete is a member of the Executive Committee of SIOPEN (European neuroblastoma research cooperative group) non-profit organization that receives royalties for the sales of dinutuximab beta. S Rives is a member of a data monitoring committee (DMC) and of de Study Steering Committee (SSC) for clinical trials sponsored by Novartis, had a consultant or advisory role for Novartis, Kite/Gilead, Juno/Bristol-Myers, Baxalta/Servier, Amgen, JazzPharma and received honoraria for speaking at symposia from Novartis, Servier, Amgen, Jazz Pharma. M. Ramírez receives grant money from Orgenesis. S. Gallego had advisory role and received personal fees from Bayer, Loxo Oncology, and EusaPharma. A. Fernández-Teijeiro had a consulting or advisory role for Amgen, Novartis, Takeda, Bayer, Roche, and Sobi. She received honoraria from Takeda, Amgen, Novartis and Sobi for educational events and travel expenses from Servier, Shire, Takeda and Gilead. L. Moreno is member of data monitoring committees for clinical trials sponsored by Novartis, Actuate Therapeutics, Shionogi, Incyte, the University of Southampton and the Royal Marsden NHS Foundation Trust; and had a consulting role for Novartis and Shionogi. Dr. Lucas Moreno is member of the Executive Committee of SIOPEN which receives royalties for the sales of dinutuximab beta. His institution receives funding from sponsors for DMC participation, advisory role or conducting industry-sponsored clinical trials. F. Bautista is a member of a DMC for a clinical trial sponsored by Sanofi, had a consultant or advisory role for Bayer, Amgen, Roche Genentech and EusaPharma and received honoraria for speaking at symposia from Roche Genentech. The rest of the authors declare that they have no conflicts of interest.

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The study does not involved human participants, their data or biological material so, according to Spanish national law.

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Rubio-San-Simón, A., Hladun Alvaro , R., Juan Ribelles , A. et al. 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). Clin Transl Oncol 23, 2489–2496 (2021).

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  • Paediatric haematology and oncology
  • Clinical trials
  • Drug development
  • Clinical research
  • Access to innovation