SAS Clinical Enrollment Simulation

SAS Clinical Enrollment Simulation is a solution designed for sponsors, contract research organizations (CROs), and site management organizations (SMOs) involved in clinical trial planning. It uses discrete event simulation to produce more accurate enrollment projections, addressing the widespread problem that approximately 90% of clinical trials fail to meet their enrollment timelines due to reliance on static assumptions and fixed estimates.

The tool allows users to enter assumptions, simulate multiple replications of the enrollment process, and visualize results in a comparable format. It supports both new trial planning and the rescue of studies with lagging enrollment, with rapid implementation enabling quick access to actionable insights.

Core Simulation Capabilities

• Uses discrete event simulation to model enrollment across multiple replications, producing probability metrics for achieving specific business targets, including the likelihood of meeting enrollment targets under a given scenario.
• Captures variability at the country and site level rather than relying on static estimates. Users input best-case, worst-case, and typical-case scenarios for each site, and a new value is drawn for each site during every simulation run.
• Models variable enrollment rates over time — for example, reflecting a peak enrollment period followed by a lower enrollment period — rather than projecting a constant monthly rate.
• Includes startup costs for countries and sites as well as per-patient costs, allowing users to assess the cost impact of different enrollment scenarios.

Key Features

• Diversity target support: Analytic capabilities based on simulated trial output help determine whether scenarios will meet key diversity targets for study enrollment.
• Accurate enrollment projections: Simulations based on multiple key inputs assess the realistic probability of successful enrollment.
• Scenario management: Supports what-if analysis and cost tracking across different planning scenarios.
• Supply chain projections: Additional capabilities support projections for estimated drug resupply timelines.
• Workforce management: Provides insights to support planning of monitoring visits.

Intended Outcomes

• Reduction of enrollment timelines by enabling faster, more strategic planning.
• Minimization of costs through scenario comparison and cost modeling.
• Greater insight into the trial enrollment process through probabilistic rather than deterministic projections.
• Ability to identify the best path forward for studies experiencing enrollment difficulties.

SAS Clinical Enrollment Simulation is part of SAS's broader life sciences analytics portfolio, which includes related products such as SAS Life Science Analytics Framework and SAS for Transforming Clinical Trial Analysis and Submission. The solution is positioned for organizations seeking to move beyond static enrollment planning toward simulation-based approaches that reflect real-world variability.