Designing clinical trials during a pandemic - some personal lessons from COVID-19

A presentation by Professor Thomas Jaki

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Abstract: Statistical Validation of Biomarkers for Use in Early Clinical Development and Biotechnology

Clinical trials are the golden standard when evaluating the potential of a novel treatment, a standard that should not be compromised during a pandemic. At the same time, there are unique challenges in conducting studies in a novel disease, such as COVID-19, and developing novel treatments during a major outbreak of the disease. For example, the limited understanding of the natural history of the disease makes it difficult to choose the primary endpoint for a study while potentially highly volatile numbers of infections makes it difficult to determine the rate and ability to recruit. In this talk Professor Jaki discusses some of the key issues in designing clinical trials during a pandemic and reflects on his experiences with COVID-19 trials to date.

About the speaker:

Thomas Jaki is Professor of Statistics at Lancaster University and Programme Leader at the MRC Biostatistics Unit at the University of Cambridge. His work focuses on efficient trials using adaptive and Bayesian methods. He is also the Director of the Medical and Pharmaceutical Statistics Research Unit which offers advice on the design and analysis of clinical studies and develops relevant novel statistical methods. He is an NIHR senior research fellow and CO-I of the Trials Methodology Research Partnership and co-leads its adaptive designs working group.

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