Advanced Topics for Biostatistics

This pharmaceutical and medical device training course begins with a brief introductory discussion that will introduce and outline the types of clinical investigations conducted.  This includes Phase II (non- randomized and randomized) and Phase III randomized clinical trials.  It will emphasize the principles of clinical investigations and the issues to be addressed in the remainder of the course.  Also the concept of the p-value and power will be reviewed. 

Statistical topics will include, but are not limited to:  

• Multiple primary and secondary endpoints in clinical trials and the techniques for addressing the multiple testing procedures that have been proposed
• Missing data in clinical trials, the types of missing data that can arise and the issues involved for handling and interpreting the results from lack of data
• Adaptive designs in clinical studies  when an interim analysis indicates a possible midway correction in study design to preserve the integrity of the study
• Addressing the problems of assessing risks in time to event studies when failure may be from competing causes. The course will cover more complex issues in research investigations and clinical trials.
• Introduction to Bayes Analysis in Clinical Studies and their comparison to the traditional hypothesis testing procedures
• Propensity scoring in the presence of many covariates and the advantages of this technique in many clinical studies
• Statistical approaches to high density data involving genetic markers as diagnostic or treatment correlates
• Brief introduction to gaining more information from meta-analysis using meta-regression and other techniques