PubMed:32472454 JSONTXT

{"project":"LitCovid-OGER-BB","denotations":[{"id":"T1","span":{"begin":74,"end":82},"obj":"SP_7"},{"id":"T2","span":{"begin":212,"end":220},"obj":"SP_7"},{"id":"T3","span":{"begin":1061,"end":1069},"obj":"SP_7"}],"namespaces":[{"prefix":"NCBITaxon","uri":"https://www.ncbi.nlm.nih.gov/taxonomy/"}],"text":"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).\nPURPOSE: 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.\nMETHODS: 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.\nRESULTS: 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).\nCONCLUSIONS: 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."}