SPEAKER: Tony Rossini, Research Assistant Professor, Department of Biostatistics, University of Washington, Seattle, Affiliate Member, Fred Hutchison Cancer Research Center
TITLE: Statistical
Issues in Early Clinical Evaluation of Vaccines
ABSTRACT:
The early phase evaluation of vaccines provides novel challenges for
both statistical design and analysis. We present 3 issues that have arisen
in the evaluation of vaccines: design of an evaluation program, presentation
of safety data, and analysis of immunogenicity data. All of the approaches
are described in the context of trials happening in the HIV Vaccine Trials
Network, and demonstrate that there can still be interesting and important
statistical issues in Phase I/II clinical trials.
COFFEE: 3:45 p.m., 104 Snedecor Hall