Application of Recent Guidance on Missing Data to Truncated Immunogenicity Data
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*John Jezorwski, Sanofi Pasteur 

Keywords: Vaccines, missing data, NRC, guidance

The FDA-commissioned National Research Council (NRC) report on the prevention and treatment of missing data in clinical trials, and the recent EMA guideline on missing data, might be expected to have implications for the way truncated immunogenicity data is analyzed in clinical trials. Classically, single imputation methods have been used for imputing values less than the lower limit of quantitation (