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How can modeling and simulation improve the clinical trial go/no-go decision-making process, accelerating drug development?

In July 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced the agency’s Innovation Initiative to support “in silico tools in clinical trials for improving drug development and making regulation more efficient.”

In silico clinical trials involve the use of computer models and simulations to develop and evaluate devices and drugs. Modeling and simulation involve taking critical information about the human body, the disease, the drug, how they interact, and how such interactions change over time, and using mathematical equations and statistics to create a model, which is a description of these relationships. We can then use the model to create an imitation of reality by simulation. In clinical trial simulation, we apply a study protocol to the model, thus recruiting “virtual” subjects, dosing them and making observations based on the model. The information we gather can help shape study design, accelerate the drug development process and increase regulatory efficiency.

The full paper can be accessed with the following hyperlink.

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