IQVIA CSO and Global Chief of Scientific Affairs Nancy Dreyer recently discussed her DIA presentation on real-world evidence (RWE), and when it’s viable in the evaluation of therapeutic interventions.
Dreyer during an interview with The Evidence Base says that while RWE has been a “mainstay for safety surveillance” following approval, there’s been growing interest in expanding its uses.
“The 21st Century Cures Act, passed in December 2016 is a formal declaration of the FDA’s interest in using RWE to modernize and accelerate the drug development process,” she said. “This legislation calls for the consideration of RWE to support label expansions after product launch as alternatives to tightly controlled and expensive RCTs.”
To read the full interview, click here.