Trial Organization and Governance

An issue impacting the success of many human efforts is the organizational and management strategy required for their successful completion. This is an important issue for any clinical trial as well. It is always a challenge to match the needs required for a successful trial with the resources available in a management strategy compatible with the experience and personalities of the collection of investigators and staff involved. Clearly the simplest situation is the single-site trial with a single investigator and few or no staff. In this situation, the investigator has only himself or herself to organize and manage. While this is no guarantee of success, it creates much less of a management burden than does a multicenter, long-term trial, especially since such endeavors typically include numerous investigators, central laboratories, reading centers, coordinating center, and a large number of committees, each with its own purpose, requirements, and personality. The organization and management (OM) issues for this situation are critically important for the overall success of the trial. This chapter highlights issues for such long-term, multicenter studies as these situations encompass all the key, major issues.