In the past, drug trials have taken months or years to conduct, with reams of data to analyze before a sponsor could go to a regulator for product approval. But under the emergency conditions caused by the COVID-19 pandemic, vaccine approvals will be based on early data analysis and much smaller data sets. While interim trial data are not usually used as proof of an investigational product’s efficacy, the urgent need for a vaccine has led drugmakers to use the data for Emergency Use Authorization (EUA) submissions, an approach WCG Statistics Collaborative President Janet Wittes says is valid under the circumstances.
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