About: Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?
Creator	Xi, Dong Friede, Tim Stallard, Nigel Zohar, Sarah Bretz, Frank »more»
source	ArXiv
abstract	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 the ongoing clinical trials in non-COVID-19 conditions. Motivated by four currently ongoing 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 utilize early readouts; and (v) how to utilize 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.
has issue date	2020-05-28(xsd:dateTime)
has license	arxiv
sha1sum (hex)	1af0c0dab777ddb7bd11224d16fe4e42b07a3898
resource representing a document's title	Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?
resource representing a document's body	covid:1af0c0dab777ddb7bd11224d16fe4e42b07a3898#body_text
is schema:about of	named entity 'pandemic' named entity 'All' named entity 'number' named entity 'pandemic' named entity 'CONDITIONS' »more»

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