Application of Survival Analysis Methodologies in Vaccine Trials
*Yanli Zhao, Biostatistics and Research Decision Sciences, Merck Research Laboratory, Merck William Wang, Biostatistics and Research Decision Sciences, Merck Research Laboratory, Merck Ivan S.F. Chan, Merck Research Laboratory, Merck Keywords: biomarker, case cohort, vaccine Applications of survival analysis methodologies in vaccine trials have some special issues and challenges. In many vaccine efficacy trials, validating a vaccine immunogenicity biomarker is an important task, yet sometimes it is often difficult or even infeasible to obtain immunogenicity measurements from the full cohort. The case-cohort and nested case-control designs have the potential to overcome this limitation due to their flexibility in subsampling. In this talk, we will first discuss the power and sample size considerations to evaluate the correlates of protection using survival methodologies, then we will discuss how to apply these case-control and case-cohort methods in vaccine studies. In addition, we will compare the performance of these two subsampling methods and a "hybrid" method, with that from the method utilizing the full cohort.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC