While simulation is used most effectively from the beginning of a clinical trial, it can be implemented at any stage of the
trial. Once the enrolling sites have been characterized for subject enrollment rates, simulation can be used to create a subject
enrollment curve along with a projected completion date. This curve can be used to continue to track the progress of the trial
and function as both an early warning indicator and a corrective action method in a manner similar to that noted earlier.
Conclusion In short, the practice of simulation in clinical trial subject enrollment enables managers to capture test center variability
in a single cohesive summary. And it brings a single flexible tool to companies that can track and address any situation that
arises in the organization, granting greater visibility over the entire project lifecycle. Companies also gain tomorrow's history today through predictive analysis. Simulation can help identify counter intuitive events
in their systems, such as sites that offer high volume enrollment but may not be the best choice if they have lengthy qualification
and enrollment startup delays. It can also provide an early indication of when and where trials are derailed. This awareness
can be combined with additional simulation scenarios to quickly identify options to help the trial recover and complete its
objectives with a minimal disturbance to the original targets. In addition, the program's results help trial managers produce more realistic, accurate goals. This makes the trial's management
case much stronger before senior executives and increases the chance that the trial will receive support. It also facilitates
cost avoidance, where companies can recognize a project's viability early in the process. If it won't be economically feasible
to reach the subject recruitment goals in any realistic time frame, management can sunset the project and save valuable resources.
Lastly, adopting simulation strategies provides risk mitigation. Companies that are new to the clinical trial process or embarking
on a trial for a disease that they've never targeted before are presented with the opportunity to gather realistic, projected
answers to some of their most pressing questions:
- How long will this trial take?
- Who do I need to participate?
- How much is it going to cost?
This, in turn, can alleviate the risks of choosing the wrong site and subjects, underestimating the clinical trial's time
frame, and going significantly over budget. Even at its best, the site and subject recruitment process is highly variable and risk-ridden. Clinical trial simulation helps
pharmaceutical companies find the right answer the first time around—and much more quickly than traditional methods. When
implemented effectively, clinical trial recruitment initiatives such as trial simulators significantly reduce timelines and
meet recruitment targets ahead of schedule. And that means the product is one step closer to hitting the marketplace and achieving
rapid return on investment, the ideal outcome. References 1. Cutting Edge Information, "Clinical Operations: Accelerating Trials, Allocating Resources & Measuring Performance" (2006),
http:// http://www.cuttingedgeinfo.com/clinicaltrialbenchmarking/index.htm.
Kurtis E. Shampine is vice president and general manager at ProModel Life Sciences Solutions, 7540 Windsor Drive, Suite 300, Allentown, PA 18195,
(860) 443-8882, email: kshampine@promodel.com
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