Clinical trial preparations for the next pandemic.
COVID-19
Centralized statistical monitoring
Drug development
Estimands
Large simple trials
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
09
11
2020
revised:
13
01
2021
accepted:
20
01
2021
pubmed:
31
1
2021
medline:
15
4
2021
entrez:
30
1
2021
Statut:
ppublish
Résumé
This paper describes the need to prepare for the development of antiviral therapeutics for the next pandemic. Preparation would consist of a stockpiling of best practices for clinical trial design, analysis and operations during the current SARS-CoV-2 pandemic as well as continuous development of treatments and methodology between pandemics. This development would be facilitated by a global clinical trial pandemic reserve similar to the military reserves consisting of medical and quantitative methods professionals who would remain engaged between pandemics. Continuous identification of potential antiviral drugs and diagnostic methods would also be needed. Specific methodology addressed includes the importance of large simple trials, follow up time, efficacy endpoint, appropriate estimands, non-inferiority trials, more sophisticated patient accrual models and procedures for data sharing between clinical trials.
Identifiants
pubmed: 33515783
pii: S1551-7144(21)00028-8
doi: 10.1016/j.cct.2021.106292
pmc: PMC7985296
pii:
doi:
Substances chimiques
Antiviral Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
106292Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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