Bristol-Myers Squibb has tapped Concerto HealthAI for a multi-year, real-world data project covering a range of different cancers.
The two companies aim to apply artificial intelligence and machine learning to multiple data sources with the ultimate goal of producing better-designed clinical trials, including synthetic control arm studies and measurements of economic outcomes.
“With the increasing importance of real-world data and real-world evidence, healthcare providers and regulators need to have confidence in the credibility and accuracy of the data sources and methods of evidence generation,” said Jeff Elton, CEO of Concerto, a SymphonyAI company.
“Our agreement with Bristol-Myers Squibb is a recognition that we have reached a pivot-point for RWE—it is not just a tool for generating insights into the current standard of care, but a field in its own right that can lead to optimization of current treatments and new therapeutic innovations,” Elton said.
RELATED: FDA commits to rapid device safety responses using real-world data and active surveillance
Concerto holds a license to harvest data from CancerLinQ, a platform maintained by the American Society of Clinical Oncology. The company works with ASCO to broaden the use of real-world evidence in pre- and post-approval studies, including through a collaboration with Tempus and the FDA’s drug evaluation center.
Concerto and Tempus, a molecular data repository builder, currently help the FDA analyze a de-identified data set provided by CancerLinQ, which covers more than 10,000 patients treated with immune checkpoint inhibitors for approved and unapproved indications.
BMS, meanwhile, has also been working with Roche’s Flatiron Health on establishing real-world data standards for regulatory submissions. It expanded its collaboration last May for another three years, with plans to form a joint scientific advisory board on the matter.