Statistical Methods for Public Health II

Catalog description

The course provides in-depth information regarding the principles behind randomized and controlled clinical trials and then delves into topics that are specific to clinical trials. Study designs determine how the data are analyzed and how to avoid/minimize clinical biases, so study designs are investigated: (a) Phase I-IV trials, (b) non-inferiority designs, (c) factorial designs, and (d) crossover designs. Next, sample size calculations are investigated to optimize precision, and the biostatistical and logistical aspects of randomization methods are described. Adaptive designs provide more efficient approaches, especially two-stage approaches. Adaptive designs are investigated for Phase II-III clinical trials. Many clinical trials invoke time-to-event outcomes, so survival analysis methods are covered in detail. Systematic reviews and meta-analyses consist of summarizing and analyzing the data across a set of independent clinical trials. In particular, fixed-effects and random-effects models for meta-analyses are explored. The final topic is medical diagnostic testing, in which clinical researchers try to identify new testing procedures for distinguishing between healthy and diseased individuals.