Overcoming “Trial Fatigue”: A Strategy for Optimizing Patient Accrual Speed and Resource Utilization

Abstract

Patient accrual in most clinical trials is characterized by a slow start during the ramp-up period, a steep mid-section, and a plateauing at the end of the accrual period. This non-linear patient accrual is costly to pharmaceutical companies. An effective measure to prevent this slowdown and to keep the accrual rate linear over time is the staggered enrollment of investigative sites in distinct waves. If the enrollment of successive waves is optimally spaced over time, the “trial fatigue” seen with each wave can be overcome, resulting in an overall linear accrual. Linear accrual can result in a steady rate of resource utilization as well as a steady rate of data retrieval over the life of a clinical trial. A clinical trial which used staggered waves is described.