C4

Chair: Xiaofei Wang (Duke)
Instructor: Sin-Ho Jung (Duke)

Traditionally a phase II trial is conducted as a single-arm trial to compare the response probabilities between an experimental therapy and a historical control. Historical control data, however, often have a small sample size, are collected from a different patient population, or use a different response assessment method, so that a direct comparison between a historical control and an experimental therapy may be severely biased. Randomized phase II trials entering patients prospectively to both experimental and control arms have been proposed to avoid any bias in such case. In this short course, we will study randomized phase II trial designs and learn how to find optimal ones. We will also review traditional single-arm phase II trial designs and study some new advances for them.

Sin-Ho Jung, PhD
Professor
Department of Biostatistics and Bioinformatics
Duke University School of Medicine

Dr. Jung received his Ph.D. degree in Statistics from University of Wisconsin-Madison. His primary research interest is design and analysis methods for clinical trials, with emphasis on phase II trials. More of his research topics include survival analysis, clustered data analysis, longitudinal data analysis, multiple testing and prediction-validation methods with high dimensional data.