Increased vulnerability of clinical research units during the COVID-19 crisis and their protection.
Betacoronavirus
/ immunology
COVID-19
Clinical Trials as Topic
Coronavirus Infections
/ diagnosis
Humans
Incidence
Medical Oncology
/ organization & administration
Neoplasms
/ therapy
Pandemics
/ prevention & control
Patient Safety
Pneumonia, Viral
/ diagnosis
Quarantine
SARS-CoV-2
Serologic Tests
Triage
/ methods
COVID-19
clinical research units
clinical trials integrity
patients’ safety
serological tests
vulnerability
Journal
Cancer
ISSN: 1097-0142
Titre abrégé: Cancer
Pays: United States
ID NLM: 0374236
Informations de publication
Date de publication:
01 09 2020
01 09 2020
Historique:
received:
20
04
2020
revised:
04
05
2020
accepted:
06
05
2020
pubmed:
20
6
2020
medline:
29
8
2020
entrez:
20
6
2020
Statut:
ppublish
Résumé
Currently, the complexity of clinical trial development in oncology is being further complicated by the coronavirus disease 2019 (COVID-19) pandemic, which is reducing the resources needed to comply with protocol-specific procedures while putting patients in units, who are already vulnerable, at increased general risk not only for COVID-19 infection but also with respect to their baseline disease. Individualizing the management of patients while ensuring their safety and adherence to the study protocol, establishing specific staff contingency plans, and maintaining sponsor and contract research organization (CRO) alignment are some of the key issues for maintaining the continuity of cancer patients' investigational treatment and minimizing their infection risk as well as the risk to staff members of the unit, sponsors, and CROs while maintaining the integrity of data quality and compliance with good clinical practice.
Identifiants
pubmed: 32557596
doi: 10.1002/cncr.32980
pmc: PMC7300769
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3907-3911Informations de copyright
© 2020 American Cancer Society.
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