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 (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
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

82-91

Informations 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.

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Auteurs

Alba Rubio-San-Simón (A)

Paediatric Haematology-Oncology Department, Children's University Hospital Niño Jesús, Madrid, Spain.

Nicolas André (N)

Paediatric Haematology-Oncology Department, Hôpital pour enfant de La Timone, AP-HM, Marseille, France.

Maria Giuseppina Cefalo (MG)

Onco-Hematology, Cell and Gene Therapy Department, Bambino Gesù Childrens Hospital, Rome, Italy.

Isabelle Aerts (I)

Paediatric Haematology-Oncology Department, Institut Curie, Paris, France.

Alicia Castañeda (A)

Paediatric Haematology-Oncology Department, Hospital Sant Joan de Déu, Barcelona, Spain.

Sarah Benezech (S)

Paediatric Haematology-Oncology Department, Institut d'Hematologie et Oncologie Pédiatrique IHOPe, Lyon, France.

Guy Makin (G)

Paediatric Haematology-Oncology Department, Royal Manchester Children's Hospital, Manchester, United Kingdom.

Natasha van Eijkelenburg (N)

Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands.

Karsten Nysom (K)

Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.

Lynley Marshall (L)

Paediatric Haematology-Oncology Department, Oak Centre for Children & Young People, The Royal Marsden Hospital & the Institute of Cancer Research, London, United Kingdom.

Marion Gambart (M)

Paediatric Haematology-Oncology Department, Hôpital des enfants CHU, Toulouse, France.

Raquel Hladun (R)

Division of Paediatric Haematology and Oncology, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.

Claudia Rossig (C)

Paediatric Haematology-Oncology Department, University Children´s Hospital, Muenster, Germany.

Luca Bergamaschi (L)

Paediatric Haematology-Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Franca Fagioli (F)

Paediatric Haematology-Oncology Department, Regina Margherita Children's Hospital, A.O.U. Citta della Salute di Torino, Torino, Italy.

Ben Carpenter (B)

Paediatric Haematology-Oncology Department, University College London Hospitals, London, United Kingdom.

Stephane Ducassou (S)

Paediatric Haematology-Oncology Department, Centre Hospitalier Universitaire (CHU), Bordeaux, France.

Cormac Owens (C)

Paediatric Haematology-Oncology Department, Children's Health Ireland, Crumlin, Dublin, Ireland.

Ingrid Øra (I)

Department of Paediatric Haematology-Oncology, University Hospital, Stockholm, Sweden.

Antonio Juan Ribelles (AJ)

Paediatric Haematology-Oncology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.

Bram De Wilde (B)

Paediatric Haematology-Oncology Department, Ghent University Hospital, Ghent, Belgium.

Pilar Guerra-García (P)

Paediatric Haematology-Oncology Department, Hospital Universitario La Paz, Madrid, Spain.

Marion Strullu (M)

Paediatric Haematology-Oncology Department, Hôpital Robert-Debré Ap-Hp, Paris, France.

Carmelo Rizzari (C)

Paediatric Haematology-Oncology Department, Clinica Pediatrica Fondazione MBBM, Monza, Italy.

Torben Ek (T)

Paediatric Haematology-Oncology Department, Childhood Cancer Centre, Gothenburg, Sweden.

Simone Hettmer (S)

Division of Paediatric Haematology-Oncology Department, Department of Paediatric and Adolescent Medicine, Faculty of Medicine, University of Freiburg, Germany.

Nicolas U Gerber (NU)

Department of Paediatric Oncology, University Children's Hospital, Zurich, Switzerland.

Christine Rawlings (C)

Paediatric Haematology-Oncology Department, Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom.

Manuel Diezi (M)

Pediatric Hematology-Oncology Unit, Division of Paediatrics, Department "Woman-Mother-Child", Lausanne University Hospital and University of Lausanne, Switzerland.

Sauli Palmu (S)

Center for Child Health Research, Tampere University and Department of Pediatrics, Tampere University Hospital, Tampere, Finland, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.

Antonio Ruggiero (A)

Paediatric Haematology-Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS -Universita' Cattolica Sacro Cuore, Rome Italy.

Jaime Verdú (J)

Paediatric Haematology-Oncology Department, Children's University Hospital Niño Jesús, Madrid, Spain.

Teresa de Rojas (T)

Paediatric Haematology-Oncology Department, Children's University Hospital Niño Jesús, Madrid, Spain.

Gilles Vassal (G)

Paediatric and Adolescent Oncology Department Gustave Roussy Cancer Campus, INSERM U1015, Université Paris-Saclay, Villejuif, France.

Birgit Geoerger (B)

Paediatric and Adolescent Oncology Department Gustave Roussy Cancer Campus, INSERM U1015, Université Paris-Saclay, Villejuif, France.

Lucas Moreno (L)

Division of Paediatric Haematology and Oncology, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.

Francisco Bautista (F)

Paediatric Haematology-Oncology Department, Children's University Hospital Niño Jesús, Madrid, Spain. Electronic address: franciscojose.bautista@salud.madrid.org.

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