ABSTRACT
There’s one well-recognized truism underlying site enrollment that needs to be acknowledged up front. Even the most conscientious and dedicated site staff tend to predict greater enrollment success than actually materializes. The result is that once a study begins, sponsors are all too often surprised at how slowly randomization actually occurs and how often enrollment periods must be extended. The gap between expectations and reality is often represented by Lasagna’s Law. In short, the law states that as soon as a study begins, the number of patients available instantly drops from a theoretical pool of 100 percent down to 20 percent; as soon as a study concludes, the pool jumps back to 100 percent.
