Chapter 17 - Study Management

Abstract

This chapter focuses on the study management of clinical trials conducted in developing regions of the world. Study management is a complex undertaking in any clinical trial, but considerably more so for large, multisite trials being conducted in developing countries. Cultural differences also need to be considered carefully. Once selected to conduct a specific clinical trial, a CRO has to create its own study team for that trial. This team will include individuals; the precise names used for these positions may differ somewhat from CRO to CRO, but the functions they perform will essentially be the same. The importance of laboratory data becomes extremely clear when one considers the fact that these data account for 70–90 percent of all data contained in marketing approval submissions to regulatory agencies. Although many companies use regional trials in developing regions to support products on a local basis, it is the ability to use locally generated data to support international regulatory submissions that is of greatest interest. Since ICH-GCP is currently less well known in many developing countries, running trials to the satisfaction of international authorities such as the FDA and the European Medicines Agency (EMA) requires huge training efforts for the local CRAs and principal investigators. CROs with global footprints can be very helpful in this regard, since they are knowledgeable about international standards and have been on the ground in developing regions for a number of years.