Using Simulation to Plan and Rescue Clinical Trial Enrollment

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Presenter: Jim Box

The key factor to successfully completing a clinical trial and achieving the required timeline is to have a solid plan that forecasts how patients will be enrolled into the trial. These forecasts are typically built from assumptions about the number of countries and investigator sites to use, how long it will take them to get operational, and what patient enrollment rates they can achieve. Unfortunately, traditional enrollment predictions using these factors are usually accomplished by applying point estimates and educated guesses that do not take variability into account. This leads to inaccurate projections that are usually not met during the trial operation. In comparison to this traditional approach, the SAS Clinical Enrollment Simulation Cloud allows the study planner to build in variability to the estimates which will show a more accurate picture of how enrollment is likely to progress and the probability of hitting key milestones. User can also modify input values to create "what if" scenarios which can identify a best path forward and be used to inform the strategic decisions when enrollment falls short of targets.