Featuring Dr. Mark Levenson, director of the Division of Biometrics VII in the Office of Biostatistics at the U.S. Food and Drug Administration
“Our biggest concern is always the safety of trial participant,” the FDA’s Dr. Levenson tells us in a July 24, 2020 discussion of the agency’s new guidance covering Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. “Sponsors should also proactively plan to address the impact of COVID-19 on the ability to meet the trial objective,” Dr. Levenson says. Modifications to the ascertainment of primary or key secondary endpoints would generally require a protocol amendment or an investigational device exemption supplement, he notes. “Modifications to the analysis of the primary or key secondary endpoints should be reflected in an updated statistical analysis plan before locking the database and before any modifications to unblinded interim analyses,” he adds.