405 – Advances in Design and Analysis of Clinical Trials
A Patient Recruitment Mixed Distribution Model with Center Initiation Cycle Times
James Powers
Quintiles, Inc.
Global, multi-center clinical trials require careful planning not only for statistical design but also to create a strategy for clinical center regulatory processes and patient recruitment targets. Anisimov and Fedorov (2007) present a Poisson-mixed-with-gamma approach to patient recruitment, which can be viewed a double-stochastic process. Practical application of that method has led to a number of practical extensions, as we add time-to-center initiation as an important cycle time. Further, we have modeled country and region-specific characteristics that lead to an overall refinement of the application of this method. The strategic decisions have an impact on time lines and ultimately overall development strategy for the compound.
