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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)

Abstract

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.

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Funding

There was no specific support for this study.

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Authors and Affiliations

Authors

Contributions

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.

Research involving human participants and/or animals

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

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Not needed for this study.

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Not needed for this study.

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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). https://doi.org/10.1007/s12094-021-02649-y

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Keywords

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