The U.S. Food and Drug Administration recently announced that it would begin using in silico clinical trials at its Center for Devices and Radiological Health as a way to help facilitate access to new innovations once the agency approves them.
The use of in silico trials, which use computer models and simulations to develop and evaluate devices and drugs, is part of the FDA’s plan to implement the 21st Century Cures Act, passed by Congress in December 2016.
Industry leaders are cautiously applauding the announcement.
Yoram Vodovotz PhD of the University of Pittsburgh/University of Pittsburg Medical Center’s McGowan Institute For Regenerative Medicine has used in silico trials in his own work, and has written of their benefits.
“In silico study in medicine is thought to have the potential to speed the rate of discovery while reducing the need for expensive lab work and clinical trials,” he said.
With regard to medical devices, the FDA’s in silico trial plans include the development of a digital library of models and a family of “virtual patients” for device testing, all while seeking consistency.
“We need to make sure that the adoption of these strategies is consistent across different medical products and across the agency,” said Scott Gottlieb, FDA Commissioner, in a recent blog post about the in silico trials.
The passing of the Cures act gave the FDA a wealth of resources and authorities, including $500 million over nine years. In silico trials are a way to forge a quicker path for breakthrough technologies to reach patients who may desperately need them.
“Access to advances in medical care is a critical component of public health,” said Gottlieb. “And the price of new technology affects the ability of people to access these new treatments. We therefore need to be mindful of the costs of our regulatory processes, to the degree that these costs also affect the availability of new innovations, and the way that they are ultimately priced.”
It’s encouraging to see the agency look for ways to be good stewards of what they’ve got in the interest of advancing health outcomes for everyone.
