Sanofi has formed an enterprise-wide collaboration with health care technology company Aetion to integrate real-world data platform Darwin with the Aetion Evidence Platform.
The collaboration aims to develop studies capable of standing up to regulatory requirements by advancing the efficiency of real-world evidence (RWE).
Sanofi’s Darwin has been designed to compile and analyse de-identified data, while the Aeition Evidence Platform analyses real-world data to uncover answers on the safety and efficacy of drugs.
The combination of these two platforms could elevate the companies’ analytical capabilities, opening up new opportunities for the development and application of medical treatments.
Sanofi Medical Evidence Generation global head Dr Bernard Hamelin said: “By integrating these platforms, we strive to make faster, more informed decisions with the potential to lead to first-in-class and best-in-class treatments that could change the practice of medicine.”
Evidence from medication use in the real-world setting can help to extrapolate data obtained in randomised controlled trials.
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RWE provides an opportunity to supplement trial data with evidence of actual product use in the health care system.
Aetion CEO Carolyn Magill said: “Our work with Sanofi further validates the value and potential for real-world evidence in drug development.
“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.”
Both Sanofi and Aetion anticipate real-world evidence will play a larger role in US Food and Drug Administration (FDA) reviews in the coming years, acting as a supplement to clinical trial data, with the agency’s draft RWE guidance expected by the end of next year.