Biotech and pharmaceutical companies must make a more concerted effort toward understanding and implementing real-world studies, an approach recently supported by Food and Drug Administration Commissioner Scott Gottlieb, IQVIA Chief Science Officer Nancy Dreyer writes in a recent opinion piece published on STAT.
Dreyer in her article says long-held criticisms about real-world evidence is no longer sustainable in a health care landscape that continues to support real-world studies.
“Regulators, patients, and payers are now demanding evidence about how treatments work in real-world settings,” she writes. “The FDA has come to understand that many of the quality concerns about real-world data can be addressed through careful design and analysis, as evident in the Framework for FDA’s real-world evidence program … .”
To read Dreyer’s full opinion piece on STAT, click here.