Conducting Clinical Trials II: Operational Execution

Abstract

The logistics of operationally executing a clinical trial are enormous. Consider a therapeutic confirmatory trial involving 5,000 subjects participating at a total of 100 investigational sites that are spread across several continents. Identifying potential subjects and then recruiting and retaining the required number is one challenge. Shipping the drug products for the clinical trial (the investigational and control drugs) to investigational sites located in various countries spread around the globe is another. Making sure that all necessary data are measured and recorded is a major task, as is managing and storing the data. And the list goes on. Of necessity, this chapter is far from exhaustive in its descriptions of operational aspects of running a clinical trial. Rather, its aim is to give you a feel of some of the challenges encountered and the ways that organizations which conduct trials function at an operational level.

Project management is a critical aspect of the clinical trial process whose importance in successful trial execution cannot be overstated.