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Activity Number:
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366
- Trial Design and Analysis Methods for COVID-19 Treatment/Prevention
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Type:
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Invited
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Date/Time:
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Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
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Sponsor:
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ENAR
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Abstract #316662
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Title:
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Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?
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Author(s):
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Cornelia Kunz and Silke Jörgens and Frank Bretz and Nigel Stallard and Kelly Van Lancker* and Dong Xi and Sarah Zohar and Christoph Gerlinger and Tim Friede
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Companies:
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Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany and Janssen-Cilag GmbH, Neuss, Germany and Novartis AG and The University of Warwick, Coventry, UK and Ghent University, Belgium and Novartis Pharmaceuticals, East Hanover, New Jersey, USA and Sorbonne Université, Paris, France and Statistics and Data Insights, Bayer AG, Berlin, Germany and University Medical Center Göttingen, Göttingen, Germany
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Keywords:
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SARS - CoV - 2;
Heterogeneity;
Interim analysis;
Design changes
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Abstract:
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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 utilize early read-outs; 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.
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Authors who are presenting talks have a * after their name.
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