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Abstract:
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Clinical trials are the gold 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 number of infections makes it difficult to determine the rate and ability to recruit. This talk will discuss some of the key issues in designing clinical trials during a pandemic and reflect on my experiences with COVID-19 trials.
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