Digital Twin Guidelines for Clinical Trials Drop Today

The use of digital twins to simulate patient populations can have a profound effect on the organization and outcome of clinical trials either by refining, reducing, or even eliminating human and animal testing. France’s Dassault Systèmes today announced the availability of what it calls “the world’s first guide for the medical device industry that outlines how to use virtual twins to accelerate clinical trials.”

Collaboration with FDA

The guide was published following the successful completion of a five-year collaboration with US FDA, said Dassault Systèmes, part of the Dassault Industries aerospace and defense conglomerate. The “Enrichment Playbook” offers medical device OEMs a pathway for the effective integration of virtual twins in the regulatory process, said the company in the news release.

The peer-reviewed, open-access 44-page publication serves as a comprehensive guide for establishing credibility in medical device in silico clinical trials. In silico refers to the development of patient-specific models to form virtual cohorts for testing the safety and efficacy of new drugs and medical devices.

The document is published in Frontiers in Medicine and a case study from the project can be accessed here.

Unprecedented accuracy in simulating patient populations

The project involved the creation of virtual twins that simulate patient populations with unprecedented accuracy, an innovative approach that allows for the refinement, reduction, and replacement of human and animal testing, according to Dassault Systèmes. Industry can access knowledge on running trials, building patient populations, and interpreting and measuring results to better understand the effects of a device before it reaches patients.

In silico clinical trials that align with FDA-recognized use of simulation in the regulatory process indeed can mitigate patient risk and significantly reduce the size of clinical trials, according to Leyla Mirmomen, founder and CEO of Optimuos, a client-based engineering company headquartered in Los Angeles. "The digital twin plays a pivotal role in this concept by providing a virtual representation that behaves like the physical counterpart,” Mirmomen told Joe Darrah in an article published earlier this year. "This enables our team to run diverse scenarios, integrate patient data, and record outputs, facilitating continuous improvement of the device while capturing valuable insights."

Ready for immediate application

The “Enrichment Playbook” could play a pivotal role in the evolution of clinical trial methodologies, according to Dassault Systèmes’ Life Sciences and Healthcare Industry Vice President Claire Biot. “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.”

The credibility assessment process outlined in the playbook is based on recommendations from FDA’s final guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions,” and appears in the CDRH/OSEL Regulatory Science Tools Catalog. It is the result of extensive collaboration among leaders from FDA’s Office of Science and Engineering Laboratories, clinical practice, academia, the medical device industry, and regulatory science, adds Dassault Systèmes.

The company’s 3DExperience platform applies digital twin technology to a range of applications from life sciences to manufacturing and infrastructure. Within the life sciences sector, the platform enables visualizing and forecasting patient responses to interventions based on virtual twins of the human body, said Dassault Systèmes.