Optimizing clinical trial design with in silico simulation

by Dr. Keith Nieforth, Senior Director PMX-SW, Certara
With the continued advancement of the COVID-19 pandemic, researchers all over the globe are dedicated to finding safe and effective treatments. Well-designed, efficient, and robust clinical trials with the highest probability of providing clear results are critical to this effort. A suboptimal trial design can add significant risk to a drug program, and we do not have neither the time nor resources to waste in the race against COVID-19.

Questions that may arise during the design of a clinical trial include:
• How fast can we run this trial?
• Can we use fewer patients?
• What is the optimal dosing schedule?
• Can we shorten assessment timeframes?
• Can we loosen inclusion/exclusion criteria?
• What happens if our treatment effect is smaller than we think?
• How do missing doses affect drug concentration and viral load?

The right answers to questions like these can make the difference between successful and failed clinical trials.

To help answer these questions, researchers can use trial simulation technology to test and explore study outcomes before exposing patients to a drug. Thousands of trials can be executed in silico while changing various design elements, such as the number of subjects or dosing based on response values or a covariate dose adjustment table, to assess their impact on desired study outcomes. Trial simulation technology can simplify building trial or population simulation models with features that support pharmacokinetics (PK), pharmacodynamics (PD), adherence, and trial design modeling. Furthermore, researchers can define study design attributes, conduct statistical and sensitivity analysis, and create graphical summaries to provide answers to tough development questions.

To aid in the search for effective COVID-19 treatments, the research community can get complimentary 3-month Trial Simulator licenses. Additionally, all Certara University’s On-Demand Courses are currently available at no cost.

To learn more about trial simulation, below are resources that may be of interest:

Halloran ME, Auranen K, Baird S, et al. Simulations for designing and interpreting intervention trials in infectious diseases.
BMC Med. 2017;15(1):223. Published 2017 Dec 29. doi:10.1186/s12916-017-0985-3

Beginner’s Guide to Performing Trial Simulation by Dr. Mark Lovern

Trial Simulator Examples Guide for NONMEM Modelers

Webinar on Simulating Viral Dynamics with New Trial Simulator

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