Application of Recent Guidance on Missing Data to Truncated Immunogenicity Data
View Presentation *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 ( |
Key Dates
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April 30 - May 22, 2013
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June 4, 2013
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August 9 - August 23, 2013
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August 23, 2013
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August 26, 2013
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September 9, 2013
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September 16 - September 18, 2013
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