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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
- Source :
- European journal of cancer (Oxford, England : 1990), r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, EUROPEAN JOURNAL OF CANCER, r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, Fundació Sant Joan de Déu, European Journal of Cancer, r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
- Publication Year :
- 2020
- Publisher :
- ELSEVIER SCI LTD, 2020.
-
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 1/March and 30/April/2020. Results Thirty-one out 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 to 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. Additionally, 26% of sites had restrictions on performing trial assessments due to local contingency plans. Almost half of the units suffered impact upon pending contracts. Most hospitals (65%) are planning on improving organizational 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.<br />Highlights • The COVID-19 pandemic has profoundly disrupted paediatric cancer clinical research. • A drastic drop in recruitment in phase I/II trials compared to 2019 was observed. • Current research needs reorganization to avoid loss of opportunities for children.
- Subjects :
- 0301 basic medicine
Male
Cancer Research
Paediatric haematology and oncology
0302 clinical medicine
Clinical trials
Neoplasms
Surveys and Questionnaires
Pandemic
Epidemiology
Child
Original Research
Clinical Trials, Phase I as Topic
Health Policy
Clinical trial
Europe
Oncology
Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA
030220 oncology & carcinogenesis
Preparedness
Healthcare policy
Female
COVID-19
medicine.medical_specialty
Drug development
Phase I as Topic
03 medical and health sciences
Clinical Trials, Phase II as Topic
medicine
Humans
Pandemics
Health policy
business.industry
SARS-CoV-2
Phase II as Topic
Cancer
medicine.disease
COVID-19, Clinical trials, Drug development, Healthcare policy, Paediatric haematology and oncology
Patient recruitment
Drug Development
030104 developmental biology
Clinical research
Family medicine
business
Subjects
Details
- ISSN :
- 09598049
- Database :
- OpenAIRE
- Journal :
- European journal of cancer (Oxford, England : 1990), r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, EUROPEAN JOURNAL OF CANCER, r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, Fundació Sant Joan de Déu, European Journal of Cancer, r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
- Accession number :
- edsair.doi.dedup.....3d336de379870758d37cf61742edcba5