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
(2020) In European Journal of Cancer 141. p.82-91- Abstract
Introduction: 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). Methods: 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. Results: 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... (More)
Introduction: 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). Methods: 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. Results: 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. Conclusion: 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.
(Less)
- author
- Rubio-San-Simón, Alba ; Øra, Ingrid LU ; Palmu, Sauli LU and Bautista, Francisco
- author collaboration
- publishing date
- 2020-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Clinical trials, COVID-19, Drug development, Healthcare policy, Paediatric haematology and oncology
- in
- European Journal of Cancer
- volume
- 141
- pages
- 82 - 91
- publisher
- Elsevier
- external identifiers
-
- scopus:85094189011
- pmid:33129040
- ISSN
- 0959-8049
- DOI
- 10.1016/j.ejca.2020.09.024
- language
- English
- LU publication?
- no
- additional info
- Funding Information: JV was supported by the 2019 ITCC-Fellowship grant. There was no other specific support for this study. Publisher Copyright: © 2020 Elsevier Ltd Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
- id
- 796e08b3-75ea-4cc1-9bea-4280d070056c
- date added to LUP
- 2021-03-16 10:23:31
- date last changed
- 2024-06-13 08:40:05
@article{796e08b3-75ea-4cc1-9bea-4280d070056c,
abstract = {{<p>Introduction: 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). Methods: 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. Results: 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. Conclusion: 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.</p>}},
author = {{Rubio-San-Simón, Alba and Øra, Ingrid and Palmu, Sauli and Bautista, Francisco}},
issn = {{0959-8049}},
keywords = {{Clinical trials; COVID-19; Drug development; Healthcare policy; Paediatric haematology and oncology}},
language = {{eng}},
pages = {{82--91}},
publisher = {{Elsevier}},
series = {{European Journal of Cancer}},
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}},
url = {{http://dx.doi.org/10.1016/j.ejca.2020.09.024}},
doi = {{10.1016/j.ejca.2020.09.024}},
volume = {{141}},
year = {{2020}},
}