Lectures and seminars SfoEpi Seminar Series in Biostatistics: Assistant Director Dean Follmann

Abstract:

Endpoint selection in clinical trials involves a variety of considerations. One important consideration is the sample size required to power a future clinical trial.  In this work, we define the sample size ratio, θ, as the ratio of sample sizes required to power a future trial. We consider in detail the setting of continuous endpoints where a Welch's t-statistic is used to analyze the data. We develop an estimator that depends on the squared ratio of estimated standardized treatment effects, and the quadrant on the plane in which they fall.  We evaluate bootstrap and profile likelihood methods for the construction of confidence intervals. Generalizations to other endpoints and testing of non-nested models are discussed. The methods are applied to analyze two different assays that measure antibody abundance using data from an Ebola vaccine field trial.

If you have any questions, please contact Erin Gabriel at Erin.Gabriel@ki.se