French drugmaker Sanofi announced Wednesday that it is leveraging the data analytics platform of New York-based Aetion to gather real-world evidence that can advance its understanding of the effectiveness, safety, and value of drugs.
Specifically, Aetion’s platform will be integrated with Sanofi’s real-world data platform called Darwin. Per the announcement of this collaboration and company-wide integration, Sanofi’s DARWIN compiles and analyzes de-identified data from hundreds of millions of patients who are battling various diseases. Meanwhile, Aetion’s platform analyzes real-world data to answer questions about which drugs are effective, safe and can actually improve outcomes.
“Today marks another important step in Sanofi’s digital transformation,” said Bernard Hamelin, Global Head of Medical Evidence Generation, Sanofi, in a news release. “By integrating these platforms we strive to make faster, more informed decisions that will lead to first-in-class and best-in-class treatments that can change the practice of medicine.”
In the same announcement, Aetion’s CEO hailed the collaboration as a strong indication of the potential of real-world evidence in the future.
“Our work with Sanofi further validates the value and potential for real-world evidence in drug development,” said Carolyn Magill. “Our companies share a common goal of using the best available data to get the right treatment to the right patient as quickly and efficiently as possible.”
The news of the collaboration comes as FDA has been trying to incorporate real-world evidence in helping to aid regulatory decisions instead of relying solely on clinical data that by definition takes place in a structured environment. The agency is expected to release RWE guidance by the end of next year.
Former FDA Commissioner Scott Gottlieb’s appointment to Aetion’s board of directors in September also highlights the growing importance of real-world evidence to pharma companies, payers, regulators and others.
Aetion is conducting an important study to test whether real-world evidence can reproduce the data shown in randomized control trials, the gold standard for how drugs are approved today. Through RCT DUPLICATE and a partnership with the FDA and Brigham and Women’s Hospital in Boston, the company is taking data from nearly 40 clinical trials and then attempting to reproduce them using real-world data to see if the results are concordant.
The goal is to see both RWE and RCT are complementary.
Photo: oonal, Getty Images
