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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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| Published in: | Clinical & translational oncology 2021-01, Vol.23 (1), p.183-189 |
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| Main Authors: | , , , , , , , , , , , |
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| cited_by | cdi_FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3 |
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| cites | cdi_FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3 |
| container_end_page | 189 |
| container_issue | 1 |
| container_start_page | 183 |
| container_title | Clinical & translational oncology |
| container_volume | 23 |
| creator | 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. |
| description | 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. |
| doi_str_mv | 10.1007/s12094-020-02399-3 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7258607</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2408191075</sourcerecordid><originalsourceid>FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3</originalsourceid><addsrcrecordid>eNp9UU1v1DAUjBCIlsIf4IDesRwCduJ8mAMSWgpbqdJWWkDcLK_9krhK7NROQPsD-V94N0sFFw6Wn59n5o09SfKSkjeUkOptoBnhLCUZiSvnPM0fJee0PBSkKB6fasLq72fJsxDuSOyWlD5NzvKMVRkr2Hnya9XJvkfbYgBjAaXv9zB2MiCo3lijZA-TN7IP0DgPqjO97pzToKRV6EHP3tgWpg5htfl2_TGlHEZpNQ5GvQMJHkfnJ2i8G44giz9BtminAK138wiuOfa3kWRCB1unDE77Q_tWojYyDlewljjIyfWu3UMUh41Vy-Fye7Xe3L5-njxpokV8cdovkq-frr6s1unN5vP16sNNqhgrp5QRzbHiWnGli53KalYRXqhaar2rClLRslFZQ3itZFllyAqyI0pFGzqPYC7zi-T9ojvOuwG1iu_wshejN4P0e-GkEf_eWNOJ1v0QVVbUJamiwOVJwLv7GcMkBhMU9r206OYgMkZqyimpigjNFqjyLgSPzcMYSsQhf7HkL2L-4pi_yCPp1d8GHyh_Ao-AfAGE8RAcenHnZm_jp_1P9jfPzb-a</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2408191075</pqid></control><display><type>article</type><title>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)</title><source>Springer Nature</source><creator>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.</creator><creatorcontrib>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.</creatorcontrib><description>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.</description><identifier>ISSN: 1699-048X</identifier><identifier>EISSN: 1699-3055</identifier><identifier>DOI: 10.1007/s12094-020-02399-3</identifier><identifier>PMID: 32472454</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>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</subject><ispartof>Clinical & translational oncology, 2021-01, Vol.23 (1), p.183-189</ispartof><rights>Federación de Sociedades Españolas de Oncología (FESEO) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3</citedby><cites>FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3</cites><orcidid>0000-0002-0421-8862</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32472454$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rubio-San-Simón, A.</creatorcontrib><creatorcontrib>Verdú-Amorós, J.</creatorcontrib><creatorcontrib>Hladun, R.</creatorcontrib><creatorcontrib>Juan-Ribelles, A.</creatorcontrib><creatorcontrib>Molero, M.</creatorcontrib><creatorcontrib>Guerra-García, P.</creatorcontrib><creatorcontrib>Pérez-Martínez, A.</creatorcontrib><creatorcontrib>Castañeda, A.</creatorcontrib><creatorcontrib>Cañete, A.</creatorcontrib><creatorcontrib>de Rojas, T.</creatorcontrib><creatorcontrib>Moreno, L.</creatorcontrib><creatorcontrib>Bautista, F.</creatorcontrib><title>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)</title><title>Clinical & translational oncology</title><addtitle>Clin Transl Oncol</addtitle><addtitle>Clin Transl Oncol</addtitle><description>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.</description><subject>Brief</subject><subject>Brief Research Article</subject><subject>Child</subject><subject>Clinical Trials as Topic</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 - prevention & control</subject><subject>Humans</subject><subject>Medical Oncology - organization & administration</subject><subject>Medical Oncology - statistics & numerical data</subject><subject>Medical Staff, Hospital - supply & distribution</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Neoplasms - epidemiology</subject><subject>Neoplasms - therapy</subject><subject>Oncology</subject><subject>Patient Care</subject><subject>Patient Selection</subject><subject>SARS-CoV-2</subject><subject>Spain - epidemiology</subject><subject>Surveys and Questionnaires</subject><issn>1699-048X</issn><issn>1699-3055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9UU1v1DAUjBCIlsIf4IDesRwCduJ8mAMSWgpbqdJWWkDcLK_9krhK7NROQPsD-V94N0sFFw6Wn59n5o09SfKSkjeUkOptoBnhLCUZiSvnPM0fJee0PBSkKB6fasLq72fJsxDuSOyWlD5NzvKMVRkr2Hnya9XJvkfbYgBjAaXv9zB2MiCo3lijZA-TN7IP0DgPqjO97pzToKRV6EHP3tgWpg5htfl2_TGlHEZpNQ5GvQMJHkfnJ2i8G44giz9BtminAK138wiuOfa3kWRCB1unDE77Q_tWojYyDlewljjIyfWu3UMUh41Vy-Fye7Xe3L5-njxpokV8cdovkq-frr6s1unN5vP16sNNqhgrp5QRzbHiWnGli53KalYRXqhaar2rClLRslFZQ3itZFllyAqyI0pFGzqPYC7zi-T9ojvOuwG1iu_wshejN4P0e-GkEf_eWNOJ1v0QVVbUJamiwOVJwLv7GcMkBhMU9r206OYgMkZqyimpigjNFqjyLgSPzcMYSsQhf7HkL2L-4pi_yCPp1d8GHyh_Ao-AfAGE8RAcenHnZm_jp_1P9jfPzb-a</recordid><startdate>20210101</startdate><enddate>20210101</enddate><creator>Rubio-San-Simón, A.</creator><creator>Verdú-Amorós, J.</creator><creator>Hladun, R.</creator><creator>Juan-Ribelles, A.</creator><creator>Molero, M.</creator><creator>Guerra-García, P.</creator><creator>Pérez-Martínez, A.</creator><creator>Castañeda, A.</creator><creator>Cañete, A.</creator><creator>de Rojas, T.</creator><creator>Moreno, L.</creator><creator>Bautista, F.</creator><general>Springer International Publishing</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-0421-8862</orcidid></search><sort><creationdate>20210101</creationdate><title>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)</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-40d9e79dc9cd5bc2847095c8addb750716fc2f098ca672e450b0ccaedd3c289a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Brief</topic><topic>Brief Research Article</topic><topic>Child</topic><topic>Clinical Trials as Topic</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 - prevention & control</topic><topic>Humans</topic><topic>Medical Oncology - organization & administration</topic><topic>Medical Oncology - statistics & numerical data</topic><topic>Medical Staff, Hospital - supply & distribution</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Neoplasms - epidemiology</topic><topic>Neoplasms - therapy</topic><topic>Oncology</topic><topic>Patient Care</topic><topic>Patient Selection</topic><topic>SARS-CoV-2</topic><topic>Spain - epidemiology</topic><topic>Surveys and Questionnaires</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rubio-San-Simón, A.</creatorcontrib><creatorcontrib>Verdú-Amorós, J.</creatorcontrib><creatorcontrib>Hladun, R.</creatorcontrib><creatorcontrib>Juan-Ribelles, A.</creatorcontrib><creatorcontrib>Molero, M.</creatorcontrib><creatorcontrib>Guerra-García, P.</creatorcontrib><creatorcontrib>Pérez-Martínez, A.</creatorcontrib><creatorcontrib>Castañeda, A.</creatorcontrib><creatorcontrib>Cañete, A.</creatorcontrib><creatorcontrib>de Rojas, T.</creatorcontrib><creatorcontrib>Moreno, L.</creatorcontrib><creatorcontrib>Bautista, F.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical & translational oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rubio-San-Simón, A.</au><au>Verdú-Amorós, J.</au><au>Hladun, R.</au><au>Juan-Ribelles, A.</au><au>Molero, M.</au><au>Guerra-García, P.</au><au>Pérez-Martínez, A.</au><au>Castañeda, A.</au><au>Cañete, A.</au><au>de Rojas, T.</au><au>Moreno, L.</au><au>Bautista, F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Clinical & translational oncology</jtitle><stitle>Clin Transl Oncol</stitle><addtitle>Clin Transl Oncol</addtitle><date>2021-01-01</date><risdate>2021</risdate><volume>23</volume><issue>1</issue><spage>183</spage><epage>189</epage><pages>183-189</pages><issn>1699-048X</issn><eissn>1699-3055</eissn><abstract>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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>32472454</pmid><doi>10.1007/s12094-020-02399-3</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-0421-8862</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1699-048X |
| ispartof | Clinical & translational oncology, 2021-01, Vol.23 (1), p.183-189 |
| issn | 1699-048X 1699-3055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7258607 |
| source | Springer Nature |
| 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 |
| title | 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) |
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