Titre
Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: A report from the Innovative Therapies for Children with Cancer (ITCC) consortium.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Rubio-San-Simón, A.
Auteure/Auteur
André, N.
Auteure/Auteur
Cefalo, M.G.
Auteure/Auteur
Aerts, I.
Auteure/Auteur
Castañeda, A.
Auteure/Auteur
Benezech, S.
Auteure/Auteur
Makin, G.
Auteure/Auteur
van Eijkelenburg, N.
Auteure/Auteur
Nysom, K.
Auteure/Auteur
Marshall, L.
Auteure/Auteur
Gambart, M.
Auteure/Auteur
Hladun, R.
Auteure/Auteur
Rossig, C.
Auteure/Auteur
Bergamaschi, L.
Auteure/Auteur
Fagioli, F.
Auteure/Auteur
Carpenter, B.
Auteure/Auteur
Ducassou, S.
Auteure/Auteur
Owens, C.
Auteure/Auteur
Øra, I.
Auteure/Auteur
Ribelles, A.J.
Auteure/Auteur
De Wilde, B.
Auteure/Auteur
Guerra-García, P.
Auteure/Auteur
Strullu, M.
Auteure/Auteur
Rizzari, C.
Auteure/Auteur
Ek, T.
Auteure/Auteur
Hettmer, S.
Auteure/Auteur
Gerber, N.U.
Auteure/Auteur
Rawlings, C.
Auteure/Auteur
Diezi, M.
Auteure/Auteur
Palmu, S.
Auteure/Auteur
Ruggiero, A.
Auteure/Auteur
Verdú, J.
Auteure/Auteur
de Rojas, T.
Auteure/Auteur
Vassal, G.
Auteure/Auteur
Geoerger, B.
Auteure/Auteur
Moreno, L.
Auteure/Auteur
Bautista, F.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1879-0852
Statut éditorial
Publié
Date de publication
2020-12
Volume
141
Première page
82
Dernière page/numéro d’article
91
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Résumé
Data regarding real-world impact on cancer clinical research during COVID-19 are scarce. We analysed the impact of the COVID-19 pandemic on the conduct of paediatric cancer phase I-II trials in Europe through the experience of the Innovative Therapies for Children with Cancer (ITCC).
A survey was sent to all ITCC-accredited early-phase clinical trial hospitals including questions about impact on staff activities, recruitment, patient care, supply of investigational products and legal aspects, between 1st March and 30th April 2020.
Thirty-one of 53 hospitals from 12 countries participated. Challenges reported included staff constraints (30% drop), reduction in planned monitoring activity (67% drop of site initiation visits and 64% of monitoring visits) and patient recruitment (61% drop compared with that in 2019). The percentage of phase I, phase II trials and molecular platforms closing to recruitment in at least one site was 48.5%, 61.3% and 64.3%, respectively. In addition, 26% of sites had restrictions on performing trial assessments because of local contingency plans. Almost half of the units suffered impact upon pending contracts. Most hospitals (65%) are planning on improving organisational and structural changes.
The study reveals a profound disruption of paediatric cancer early-phase clinical research due to the COVID-19 pandemic across Europe. Reported difficulties affected both patient care and monitoring activity. Efforts should be made to reallocate resources to avoid lost opportunities for patients and to allow the continued advancement of oncology research. Identified adaptations to clinical trial procedures may be integrated to increase preparedness of clinical research to futures crises.
A survey was sent to all ITCC-accredited early-phase clinical trial hospitals including questions about impact on staff activities, recruitment, patient care, supply of investigational products and legal aspects, between 1st March and 30th April 2020.
Thirty-one of 53 hospitals from 12 countries participated. Challenges reported included staff constraints (30% drop), reduction in planned monitoring activity (67% drop of site initiation visits and 64% of monitoring visits) and patient recruitment (61% drop compared with that in 2019). The percentage of phase I, phase II trials and molecular platforms closing to recruitment in at least one site was 48.5%, 61.3% and 64.3%, respectively. In addition, 26% of sites had restrictions on performing trial assessments because of local contingency plans. Almost half of the units suffered impact upon pending contracts. Most hospitals (65%) are planning on improving organisational and structural changes.
The study reveals a profound disruption of paediatric cancer early-phase clinical research due to the COVID-19 pandemic across Europe. Reported difficulties affected both patient care and monitoring activity. Efforts should be made to reallocate resources to avoid lost opportunities for patients and to allow the continued advancement of oncology research. Identified adaptations to clinical trial procedures may be integrated to increase preparedness of clinical research to futures crises.
Sujets
PID Serval
serval:BIB_F5CB19227A49
PMID
Open Access
Oui
Date de création
2020-11-09T08:35:51.985Z
Date de création dans IRIS
2025-05-21T06:18:30Z
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Nom
33129040_BIB_F5CB19227A49.pdf
Version du manuscrit
published
Taille
558.33 KB
Format
Adobe PDF
PID Serval
serval:BIB_F5CB19227A49.P001
URN
urn:nbn:ch:serval-BIB_F5CB19227A492
Somme de contrôle
(MD5):0fc23409c98f2d14765020612f8f6efb