Case-Cohort Data Analyses with an Application in Vaccine Trial

• Activity Number: 522
• Type: Contributed
• Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Shu-Chih Su*+ and Guanghan Liu and Ivan Chan
• Companies: Merck Research Laboratories and Merck Research Laboratories and Merck
• Keywords: Case-cohort ; efficacy ; immunogenicity

Abstract

Case-cohort data analyses usually only utilize the data available in case-cohort members and ignore the remaining samples which might potentially provide valuable information. Our work is motivated by Breslow (2008) where it is shown that after utilizing all available information obtained in the whole study through adjustment of the sampling weights via calibration or estimation, the precision of estimates is greatly improved. To evaluate this proposed methodology in real work, we will implement this proposed methodology to an existing large scale vaccine trial for evaluating the immunogenicity and an correlate between immunogenicity and efficacy. In this trial, the case-cohort design is desired for immunogenicity measurement collection and analysis so that expensive assay measurements need not be collected for everyone. We will quantify the potential efficiency gains of this adjusted analysis approach versus the common approach using this existing vaccine trial.