Design and Conduct of Clinical Trials

Goals and Objectives

To expose participants to the relevance of the Food and Drug Act to the design and conduct of clinical trials.

 


To convey an understanding of the differences between Phase I, II, III, and IV Clinical Trials.

 


To develop a framework for understanding data management techniques, at both the macro (rapidly evolving technologies) and the micro (individual trials) level.

 


To emphasize the practical aspects of conducting clinical trials and how to avoid pitfalls and the need for rework.

 


To explore methods of conducting trials in complex patients and how to "connect" with national studies and industry.

 


To understand methods of translating the results of clinical trials to improved health and optimal patient outcomes.