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.

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Serval ID
serval:BIB_F5CB19227A49
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
European journal of cancer
Author(s)
Rubio-San-Simón A., André N., Cefalo M.G., Aerts I., Castañeda A., Benezech S., Makin G., van Eijkelenburg N., Nysom K., Marshall L., Gambart M., Hladun R., Rossig C., Bergamaschi L., Fagioli F., Carpenter B., Ducassou S., Owens C., Øra I., Ribelles A.J., De Wilde B., Guerra-García P., Strullu M., Rizzari C., Ek T., Hettmer S., Gerber N.U., Rawlings C., Diezi M., Palmu S., Ruggiero A., Verdú J., de Rojas T., Vassal G., Geoerger B., Moreno L., Bautista F.
ISSN
1879-0852 (Electronic)
ISSN-L
0959-8049
Publication state
Published
Issued date
12/2020
Peer-reviewed
Oui
Volume
141
Pages
82-91
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.
Keywords
COVID-19/diagnosis, COVID-19/epidemiology, 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, Neoplasms/therapy, Pandemics, SARS-CoV-2/isolation & purification, Surveys and Questionnaires, COVID-19, Clinical trials, Drug development, Healthcare policy, Paediatric haematology and oncology
Pubmed
Web of science
Open Access
Yes
Create date
09/11/2020 9:35
Last modification date
25/01/2024 7:47
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