Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?
Design changes
Heterogeneity
Interim analysis
SARS-CoV-2
Journal
Statistics in biopharmaceutical research
ISSN: 1946-6315
Titre abrégé: Stat Biopharm Res
Pays: United States
ID NLM: 101507745
Informations de publication
Date de publication:
19 Aug 2020
19 Aug 2020
Historique:
entrez:
30
6
2021
pubmed:
1
7
2021
medline:
1
7
2021
Statut:
epublish
Résumé
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated by four current clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve Type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to use early read-outs; and (v) how to use Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed.
Identifiants
pubmed: 34191979
doi: 10.1080/19466315.2020.1799857
pii: 1799857
pmc: PMC8011492
doi:
Types de publication
Journal Article
Langues
eng
Pagination
461-477Informations de copyright
© 2020 American Statistical Association.
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