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.
COVID-19
/ diagnosis
Child
Clinical Trials, Phase I as Topic
/ statistics & numerical data
Clinical Trials, Phase II as Topic
/ statistics & numerical data
Drug Development
/ statistics & numerical data
Europe
/ epidemiology
Female
Health Policy
Humans
Male
Neoplasms
/ epidemiology
Pandemics
SARS-CoV-2
/ isolation & purification
Surveys and Questionnaires
COVID-19
Clinical trials
Drug development
Healthcare policy
Paediatric haematology and oncology
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
16
09
2020
accepted:
25
09
2020
pubmed:
1
11
2020
medline:
5
1
2021
entrez:
31
10
2020
Statut:
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.
Identifiants
pubmed: 33129040
pii: S0959-8049(20)31029-7
doi: 10.1016/j.ejca.2020.09.024
pmc: PMC7546235
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
82-91Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest statement N. André reports a consulting or advisory role for Bayer, BMS and Akina. He received funding for trial from BMS and molecules for trials from BMS and Pierre Fabre. He received travel support from BMS. K. Nysom reports a consulting or advisory role for YmAbs and Bayer and receiving honoraria from YmAbs and Bayer. L. Marshall reports a consulting or advisory role for Bayer, BMS, Eisai and Tesaro and receiving honoraria from Bayer for speaking in symposia/educational events. M. Gambart reports a consulting or advisory role for Bayer and receiving grants for travel expenses from Jazz pharmaceutical and Eusapharma. C. Rossig reports receiving honoraria for educational presentations and advice by Amgen, Pfizer, Celgene, Roche, BMS, Novartis and Genentech. F. Fagioli reports a consultant or advisory role for Amgen, Jazz Pharmaceuticals, Pfizer, Sanofi Genzyme and Takeda. I. Øra reports a consulting or advisory role for and receiving honoraria from Bayer. B. De Wilde reports a consultant or advisory role for Bayer, Roche and Novartis. C. Rizzari reports receiving personal and/or institutional grants, travel support and consultation fees from Amgen, Jazz Pharmaceuticals, SOBI and Servier. S. Palmu reports a consulting or advisory role for Boehringer Ingelheim and receiving honoraria for educational events and travel expenses from Octapharma and Sobi. L. Moreno reports being a member of a data monitoring committees for clinical trials sponsored by Novartis, Actuate Therapeutics, Shionogi, Incyte, the University of Southampton and the Royal Marsden NHS Foundation Trust; a consulting role for Novartis and Shionogi. He also reports being a member of the Executive Committee of SIOPEN (European neuroblastoma research cooperative group), organisation which receives royalties for the sales of dinutuximab beta. He reports that his institution receives funding from sponsors for DMC participation, advisory role or conducting industry-sponsored clinical trials. F. Bautista reports a consultant or advisory role for Bayer, Amgen, Sanofi and EusaPharma and receiving honoraria for speaking at symposia from Amgen and Jazz Pharmaceuticals and support for attending symposia from Takeda, EusaPharma, Shire and Jazz Pharmaceuticals. The rest of the authors declare that they have no conflict of interest.
Références
Science. 2020 Feb 21;367(6480):836-837
pubmed: 32079750
Pediatr Blood Cancer. 2020 Jul;67(7):e28327
pubmed: 32239747
Ann Oncol. 2020 May;31(5):553-555
pubmed: 32201224
JAMA. 2020 Jun 2;323(21):2135-2136
pubmed: 32211830
Nature. 2020 Apr;580(7801):15-16
pubmed: 32214240
Nat Rev Drug Discov. 2010 Mar;9(3):203-14
pubmed: 20168317
J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135
pubmed: 32324855
J Pediatr Hematol Oncol. 2015 Mar;37(2):e102-10
pubmed: 25171452
JCO Oncol Pract. 2020 Jul;16(7):417-421
pubmed: 32396491
Lancet Oncol. 2020 Mar;21(3):335-337
pubmed: 32066541
Contemp Clin Trials. 2008 Sep;29(5):756-61
pubmed: 18577469
Clin Cancer Res. 2020 Jul 1;26(13):3100-3103
pubmed: 32312892
Clin Cancer Res. 2013 Mar 15;19(6):1315-25
pubmed: 23329813
Nat Cancer. 2020 Jun;1(6):568-572
pubmed: 35121973
Nat Med. 2020 Apr;26(4):443
pubmed: 32242126
Contemp Clin Trials Commun. 2019 Nov 12;16:100487
pubmed: 31872156
Acta Paediatr. 2020 Jun;109(6):1088-1095
pubmed: 32202343
Cancer Treat Rev. 2010 Jun;36(4):328-34
pubmed: 20231057
Clin Transl Oncol. 2021 Jan;23(1):183-189
pubmed: 32472454
Nat Rev Clin Oncol. 2017 Aug;14(8):497-507
pubmed: 28508875
Pediatr Blood Cancer. 2020 Jul;67(7):e28409
pubmed: 32400924