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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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Harvard

Rubio-San-Simón, A, André, N, Cefalo, MG, 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, AJ, De Wilde, B, Guerra-García, P, Strullu, M, Rizzari, C, Ek, T, Hettmer, S, Gerber, NU, Rawlings, C, Diezi, M, Palmu, S, Ruggiero, A, Verdú, J, de Rojas, T, Vassal, G, Geoerger, B, Moreno, L & Bautista, F 2020, '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', European Journal of Cancer, vol. 141, pp. 82-91. https://doi.org/10.1016/j.ejca.2020.09.024

APA

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., ... Bautista, F. (2020). 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. European Journal of Cancer, 141, 82-91. https://doi.org/10.1016/j.ejca.2020.09.024

CBE

Rubio-San-Simón A, André N, Cefalo MG, 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 AJ, De Wilde B, Guerra-García P, Strullu M, Rizzari C, Ek T, Hettmer S, Gerber NU, Rawlings C, Diezi M, Palmu S, Ruggiero A, Verdú J, de Rojas T, Vassal G, Geoerger B, Moreno L, Bautista F. 2020. 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. European Journal of Cancer. 141:82-91. https://doi.org/10.1016/j.ejca.2020.09.024

MLA

Vancouver

Author

Rubio-San-Simón, Alba ; André, Nicolas ; Cefalo, Maria Giuseppina ; Aerts, Isabelle ; Castañeda, Alicia ; Benezech, Sarah ; Makin, Guy ; van Eijkelenburg, Natasha ; Nysom, Karsten ; Marshall, Lynley ; Gambart, Marion ; Hladun, Raquel ; Rossig, Claudia ; Bergamaschi, Luca ; Fagioli, Franca ; Carpenter, Ben ; Ducassou, Stephane ; Owens, Cormac ; Øra, Ingrid ; Ribelles, Antonio Juan ; De Wilde, Bram ; Guerra-García, Pilar ; Strullu, Marion ; Rizzari, Carmelo ; Ek, Torben ; Hettmer, Simone ; Gerber, Nicolas U ; Rawlings, Christine ; Diezi, Manuel ; Palmu, Sauli ; Ruggiero, Antonio ; Verdú, Jaime ; de Rojas, Teresa ; Vassal, Gilles ; Geoerger, Birgit ; Moreno, Lucas ; Bautista, Francisco. / 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. In: European Journal of Cancer. 2020 ; Vol. 141. pp. 82-91.

Bibtex

@article{73a7119bb0504b1c90eefa436f7cd001,
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",
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 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.",
keywords = "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",
author = "Alba Rubio-San-Sim{\'o}n and Nicolas Andr{\'e} and Cefalo, {Maria Giuseppina} and Isabelle Aerts and Alicia Casta{\~n}eda and Sarah Benezech and Guy Makin and {van Eijkelenburg}, Natasha and Karsten Nysom and Lynley Marshall and Marion Gambart and Raquel Hladun and Claudia Rossig and Luca Bergamaschi and Franca Fagioli and Ben Carpenter and Stephane Ducassou and Cormac Owens and Ingrid {\O}ra and Ribelles, {Antonio Juan} and {De Wilde}, Bram and Pilar Guerra-Garc{\'i}a and Marion Strullu and Carmelo Rizzari and Torben Ek and Simone Hettmer and Gerber, {Nicolas U} and Christine Rawlings and Manuel Diezi and Sauli Palmu and Antonio Ruggiero and Jaime Verd{\'u} and {de Rojas}, Teresa and Gilles Vassal and Birgit Geoerger and Lucas Moreno and Francisco Bautista",
note = "Copyright {\textcopyright} 2020 Elsevier Ltd. All rights reserved.",
year = "2020",
month = dec,
doi = "10.1016/j.ejca.2020.09.024",
language = "English",
volume = "141",
pages = "82--91",
journal = "European Journal of Cancer, Supplement",
issn = "0959-8049",
publisher = "Pergamon",

}

RIS

TY - JOUR

T1 - Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe

T2 - A report from the Innovative Therapies for Children with Cancer (ITCC) consortium

AU - Rubio-San-Simón, Alba

AU - André, Nicolas

AU - Cefalo, Maria Giuseppina

AU - Aerts, Isabelle

AU - Castañeda, Alicia

AU - Benezech, Sarah

AU - Makin, Guy

AU - van Eijkelenburg, Natasha

AU - Nysom, Karsten

AU - Marshall, Lynley

AU - Gambart, Marion

AU - Hladun, Raquel

AU - Rossig, Claudia

AU - Bergamaschi, Luca

AU - Fagioli, Franca

AU - Carpenter, Ben

AU - Ducassou, Stephane

AU - Owens, Cormac

AU - Øra, Ingrid

AU - Ribelles, Antonio Juan

AU - De Wilde, Bram

AU - Guerra-García, Pilar

AU - Strullu, Marion

AU - Rizzari, Carmelo

AU - Ek, Torben

AU - Hettmer, Simone

AU - Gerber, Nicolas U

AU - Rawlings, Christine

AU - Diezi, Manuel

AU - Palmu, Sauli

AU - Ruggiero, Antonio

AU - Verdú, Jaime

AU - de Rojas, Teresa

AU - Vassal, Gilles

AU - Geoerger, Birgit

AU - Moreno, Lucas

AU - Bautista, Francisco

N1 - Copyright © 2020 Elsevier Ltd. All rights reserved.

PY - 2020/12

Y1 - 2020/12

N2 - 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.

AB - 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.

KW - COVID-19/diagnosis

KW - Child

KW - Clinical Trials, Phase I as Topic/statistics & numerical data

KW - Clinical Trials, Phase II as Topic/statistics & numerical data

KW - Drug Development/statistics & numerical data

KW - Europe/epidemiology

KW - Female

KW - Health Policy

KW - Humans

KW - Male

KW - Neoplasms/epidemiology

KW - Pandemics

KW - SARS-CoV-2/isolation & purification

KW - Surveys and Questionnaires

U2 - 10.1016/j.ejca.2020.09.024

DO - 10.1016/j.ejca.2020.09.024

M3 - Journal article

C2 - 33129040

VL - 141

SP - 82

EP - 91

JO - European Journal of Cancer, Supplement

JF - European Journal of Cancer, Supplement

SN - 0959-8049

ER -

ID: 61992420