Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency: Guidance for Industry | NLM

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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency: Guidance for Industry

06/01/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 6/2020. This nine-page guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. It outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty. (PDF)