Managing oncology clinical trials during COVID-19 pandemic.
COVID-19
Oncology clinical trials
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
27
04
2020
revised:
14
07
2020
accepted:
09
08
2020
entrez:
25
8
2020
pubmed:
25
8
2020
medline:
25
8
2020
Statut:
ppublish
Résumé
São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-up. The management of the tightly controlled environment of clinical research becomes a challenge, and the Food and Drug Administration set of priority recommendations for patient safety while maintaining study integrity. Fast adaptations are necessary, and actions coalesce to participant protection from COVID-19. We pointed out critical processes for adjustments, and we believe that our experience may help other academic health centers.
Identifiants
pubmed: 32835128
doi: 10.1016/j.conctc.2020.100637
pii: S2451-8654(20)30121-6
pii: 100637
pmc: PMC7424329
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100637Informations de copyright
© 2020 The Authors.
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