National Pharmaceutical Council (NPC) Vice President of Comparative Effectiveness Research Jennifer Graff during an interview with Managed Care said real-world evidence could be used consistently used in the next 10 years.
“Whether this is ultimately a 10-year or 40-year evolution will be determined by how quickly cultural changes occur,” Graff said. “Will data be interoperable to routinely allow RWE analyses? Will there be enough data scientists who can use credible methods?”
The Food and Drug Administration (FDA) has also taken cautious first steps toward implementing RWE on a consistent basis, Graff said, adding that the agency in its 2019 budget request sought $100 million for a modernized RWE system.
“The FDA requires a high level of certainty in their decision making, and we see that in their measured approach,” Graff said. “However, FDA is not just putting forth a single guidance; they have a robust program including many forthcoming guidance documents.”
To read the full interview on Managed Care, click here.