Proving Beyond a Shadow of a Doubt: Can It Be Done with Statistics?

• Activity Number: 606
• Type: Contributed
• Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Oliver Bautista*+
• Companies: Merck
• Keywords: Predictive values ; likelihood ratio positive ; HPV vaccine ; HPV-related persistent infection

Abstract

A critical tenet in human papillomavirus (HPV) vaccine research is persistent infection by HPV is a precursor to high-grade HPV-related disease. The incidence of high-grade disease related to some HPV types is low and such disease may not be observable in clinical trials, whereas the incidence of persistent infection due to the same HPV types is relatively high and is observable in clinical trials. A claim that a vaccine prevents disease related to an HPV type that was sparsely observed in clinical trials may be supported by a demonstration of vaccine efficacy against persistent infection related to such HPV type and evidence that persistent infection by such HPV type is a precursor to progression to high-grade disease related to such HPV type. Analysis of the predictive value of persistent infection as a precursor to progression to high-grade disease has been performed on data from quadrivalent- and nanovalent-HPV vaccine programs using the likelihood ratio positive statistics. Results of the analysis performed contribute to the growing body of evidence towards proving beyond a shadow of a doubt that persistent infection by HPV is a precursor to high-grade HPV-related disease.