In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biosta

Sin-Ho Jung is a professor of biostatistics and bioinformatics at Duke University School of Medicine. He earned a PhD from the University of Wisconsin-Madison. His research interests include clinical trial design, survival analysis, longitudinal data analysis, clustered data analysis, ROC curve analysis, and microarray studies.

Introduction. Single-Arm Phase II Trial Designs. Inference on the Binomial Probability in Single-Arm Multistage Clinical Trials. Single-Arm Phase II Clinical Trials with Time-to-Event Endpoints. Single-Arm Phase II Trials with Heterogeneous Patient Populations: Binary and Survival Outcomes. Randomized Phase II Trials for Selection: No Prospective Control Arms. Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (I): Two-Sample Binomial Test. Randomized Phase II Cancer Clinical Trials with a Prospective Control on Binary Endpoints (II): Fisher's Exact Test. Randomized Phase II Trials with Heterogeneous Patient Populations: Stratified Fisher's Exact Test. Randomized Phase II Clinical Trials Based on Survival Endpoints: Two-Sample Log-Rank Test. Some Flexible Phase II Clinical Trial Designs. Index.