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BIOS Seminar: The sps3 experience
February 14 @ 3:30 pm - 4:30 pm
Leslie McClure, PhD, professor and chair of epidemiology and biostatistics at Drexel University’s Dornsife School of Public Health, will present “A Post-Hoc Evaluation of a Sample Size Re-estimation: The SPS3 Experience,”
Methodologically, Dr. McClure is interested in the design and analysis of randomized clinical trials with multiple outcomes, and methodology for re-estimating sample size in on-going randomized trials. She is the principle investigator for the Coordinating Center for the CDC-sponsored Diabetes LEAD (Location, Environmental Attributes, and Disparities) Network, with a primary goal of furthering our understanding of the role of community-level factors and geographic differences in diabetes incidence and prevalence across the US and across demographic groups.
The use of adaptive designs has been increasing in randomized clinical trials. Sample size re-estimation is a type of adaptation in which nuisance parameters are estimated at an interim point in the trial and the sample size re-computed based on these estimates. However, post-hoc evaluations of adaptations, including sample size re-estimations, have not
frequently been performed, leaving questions about the gains that come from utilizing these procedures in practice. In this talk, I describe the statistical impact of implementing a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes (SPS3) study and describe the effect of the adaptation on the practical aspects of the study.