While regulators have expressed interest in facilitating real-world evidence (RWE) in the drug development pipeline, a number of key obstacles, such as infrastructure and data concerns, remain, according to a PMLiVE report.
Drugmaker Pfizer recently was able to lean on data from electronic health records to earn FDA approval on a new indication for Ibrance, a breast cancer drug. The move marked a significant move forward for the use of RWE and real-world data.
“We appreciate that our partnership with the FDA has allowed us to take a significant step forward in the use of real-world data to bring medicines to patients who are most in need,” Pfizer said. “Real-world data is playing an increasingly important role in expanding the use of already approved, innovative medicines.”
To read the full report, click here.