Dassault rolls out FDA-backed guide on using virtual twins in device trials
Dassault Systèmes has launched a guide to help medical device developers use “virtual twins” in clinical trials.
The 44-page, peer-reviewed document – developed with the US Food and Drug Administration – focuses on “establishing credibility” in trials where computer models are used to simulate patient populations.
The guide, called the “Enrichment Playbook,” is based on recommendations from the FDA’s 2023 guidelines on the use of computational modeling and simulation in medical device trials. The document is included in the FDA’s Regulatory Science Tools Catalog, which provides a peer-reviewed resource for use where standards and qualified medical device development tools do not exist.
Dassault Systèmes describes virtual twins as “an innovative approach that allows for the refinement, reduction, and replacement of human and animal testing.”
It added that, by using digital twins in trials, industry can build more representative patient populations and interpret virtual results to better understand the effects of a device before it reaches a patient.
Claire Biot, vice president, life sciences and healthcare industry, at Dassault Systèmes, said, “As the healthcare industry continues to embrace digital transformation, the enrichment playbook represents a pivotal moment in the evolution of clinical trial methodologies.
“The strong participation and input from diverse experts was crucial in ensuring that the playbook meets the highest scientific and regulatory standards and is highly practical for immediate application in the field. We remain committed to driving collaborative innovation in this sector to improve the patient experience.”
Digital drive
For the FDA, the collaboration aligns with its support for greater use of digital modeling in healthcare and clinical development.
Early last month, for example, the agency, in collaboration with the National Institutes of Health (NIH) and the National Science Foundation, awarded $6 million in research funding to projects exploring digital twins in healthcare and biomedical research.
At the time, Yulia Gel, program director in the NSF Division of Mathematical Sciences, said, “Digital twins have the potential to remove common medical risks involved in patient monitoring and treatment, providing a framework for optimal decision-making.
“Real-world use of these complex models could streamline clinical trials for safer development of drugs and medical devices,” Gel said.
Unsplash/Aaron Burden