Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: a report from the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

Purpose The COVID-19 pandemic has forced healthcare stakeholders towards challenging decisions. We analyse the impact of the pandemic on the conduct of phase I–II trials for paediatric cancer during the first month of state of alarm in Spain. Methods A questionnaire was sent to all five ITCC-accredi...

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Bibliographic Details
Published in:Clinical & translational oncology 2021-01, Vol.23 (1), p.183-189
Main Authors: Rubio-San-Simón, A., Verdú-Amorós, J., Hladun, R., Juan-Ribelles, A., Molero, M., Guerra-García, P., Pérez-Martínez, A., Castañeda, A., Cañete, A., de Rojas, T., Moreno, L., Bautista, F.
Format: Article
Language:English
Subjects:
Brief
Brief Research Article
Child
Clinical Trials as Topic
COVID-19 - epidemiology
COVID-19 - prevention & control
Humans
Medical Oncology - organization & administration
Medical Oncology - statistics & numerical data
Medical Staff, Hospital - supply & distribution
Medicine
Medicine & Public Health
Neoplasms - epidemiology
Neoplasms - therapy
Oncology
Patient Care
Patient Selection
SARS-CoV-2
Spain - epidemiology
Surveys and Questionnaires
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Summary:Purpose The COVID-19 pandemic has forced healthcare stakeholders towards challenging decisions. We analyse the impact of the pandemic on the conduct of phase I–II trials for paediatric cancer during the first month of state of alarm in Spain. Methods A questionnaire was sent to all five ITCC-accredited Spanish Paediatric Oncology Early Phase Clinical Trial Units, including questions about impact on staff activities, recruitment, patient care, supply of investigational products, and legal aspects. Results All units suffered personnel shortages and difficulties in enrolling patients, treatment continuity, or performing trial assessments. Monitoring activity was frequently postponed (73%), and 49% of on-going trials interrupted recruitment. Only two patients could be recruited during this period (75% reduction in the expected rate). Conclusions The COVID-19 crisis has significantly impacted clinical research practice and access to innovation for children with cancer. Structural and functional changes are under way to better cope with the expected future restrictions.
ISSN:1699-048X
1699-3055
DOI:10.1007/s12094-020-02399-3