FDA Issues Guidance for Clinical Trials during the COVID-19 Public Health Emergency

The U.S. Food & Drug Administration (FDA) has issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”

The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments.

To help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty, this guidance addresses statistical considerations for proposed changes to trial conduct due to the COVID-19 pandemic that may impact the analysis and interpretation of the primary or key secondary endpoints in the trial.