Food and Drug Administration Looks to Use Modelling and Simulation to Improve Clinical Trial Designs
Aug 7, 2019
“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials,” Tina Morrison, deputy director of applied mechanics in the FDA’s Center for Devices and Radiological Health, said in a statement.
Through this new request for information (RFI) the FDA is seeking modelling and simulation software that can provide necessary information to develop and improve current medical devices used on the heart, such as pacemakers, without having to use more traditional trial methods. Acceptable modelling and simulation software should be capable of functions that include:
- Incorporates the three fundamental physics represented in the heart-electrical, structural, fluid;
- Spatially includes all four heart chambers as well as its peripheral vasculature
- Provides a computational human heart model that allows for electrophysiology and electromechanics of the heart
For further information and to submit a capability statement, click here: https://www.fbo.gov/index.php?s=opportunity&mode=form&id=fb56bc8127a061df7a37950ab185486d&tab=core&_cview=0