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Activity Number: 42
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #314796
Title: An Innovative Solution to Address Missing Data Problem to Estimate the Immune Response in Vaccine Trials
Author(s): Manoj Thakur* and John Jezorwski and Robert D. Small
Companies: Sanofi Pasteur and Sanofi Pasteur and Sanofi Pasteur
Keywords: Missing data ; Multiple imputation ; Random effects
Abstract:

The endpoint of vaccine clinical trials designed to assess immune response to vaccination is usually defined to be the antibody level (measured by titer/concentration) on a particular day after completion of vaccination. These trials are longitudinal trials with multiple vaccinations and boosters and bleeds. In a large trial a significant number of individuals do not return on the specified date or within a pre-defined window around the specified date. These subjects are therefore not included in the per protocol analyses; consequently, there is a significant loss in sample size and therefore power. We propose an innovative solution to the above problem that allows the use of all data regardless of timing of visit. The method combines standard missing data techniques (multiple imputation) and random effects longitudinal models to estimate the value on the protocol specified date resulting in tighter confidence intervals compared to standard method when subjects are not included in the analysis due to violation of blood sampling window. This method also includes the protocol violators who visit out of an arbitrary defined window.


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

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