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Article Dans Une Revue Statistics in Biopharmaceutical Research Année : 2020

Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?

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.

Dates et versions

hal-03122985 , version 1 (27-01-2021)

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Citer

Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly van Lancker, et al.. Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?. Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.461-477. ⟨10.1080/19466315.2020.1799857⟩. ⟨hal-03122985⟩
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