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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
Abstract #317607
Title: COVID-19 Pandemic Impact on Data Analysis in Infectious Disease Clinical Trials
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.


Authors who are presenting talks have a * after their name.

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