COVID-19 Pandemic Impact on Data Analysis in Infectious Disease Clinical Trials

• Activity Number: 249 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
• Type: Roundtables
• Date/Time: Wednesday, August 11, 2021 : 12:00 PM to 1:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Hong Wan*
• Companies: Merck
• Keywords: COVID-19; Missing Data; Infection Disease; Clinical Trials

Abstract

FDA had issued guidance on conduct of clinical trials during COVID-19 Pandemic. To access the COVID-19 Pandemic’s impact on conduct of clinical trials, the first step may be to gather information about what data and how much data are missing. Does your company or institution track the data about COVID-19 related study disruption through case report form, or protocol deviation, or any other way? Ideally, much of the missing data due to COVID-19 can likely be considered as MCAR or MAR. And original missing data approaches in the protocol might be applied without additional sensitivity analyses. In infection disease, missing-as-failure-like approach is often the primary analysis approach. If a study has few COVID-19 related missing data on key endpoints, sensitivity analyses may not be needed. The type and extent of sensitivity analyses may vary by study and depend on how much missing data due to COVID-19.