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)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has 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 Gerlinger, Christoph Jörgens, Silke Kunz, Cornelia Lancker, Kelly
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
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