Gottlieb Says Real-World Evidence is Here to Stay

Former FDA Commissioner Scott Gottlieb, MD

Unlike some other buzzwords and shiny tools, the concept of leveraging real-world evidence (RWE) in clinical trials isn’t going anywhere. At least that’s the assessment of big RWE fan and former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD.

RWE is here to stay, Gottlieb says, in part because Congress has finally put money and political muscle behind it—at his behest.

FDA received “substantial resources” in the 2019 budget to make “wholesale use of [RWE] to look at questions of drug and device safety,” Gottlieb says. That’s going to change things “culturally inside the agency,” he adds.

For the first time, the agency has substantial financial resources to consolidate data from electronic health records, Gottlieb notes. The agency also has a mandate from Congress to make use of those data when investigating drug and device safety questions under post-marketing conditions.

“I think that’s going to be an inflection point in the culture of the agency. Now that FDA review staff are going to be embedded and thinking about how to use RWE more effectively for their own purposes, it will make it easier for them to embrace” the clinical trial industry’s use of it as well, Gottlieb told attendees of the 9th Annual DPharm: Disruptive Innovations conference in Boston today (September 17).

Lauded as a “passionate promoter of innovation” by event co-chair Tammy Guld, Janssen Clinical Innovation Global Team Lead for Johnson & Johnson, Gottlieb says he had worked hard with others at FDA to help promote advances in clinical trials by honing regulations in both arcane and more broadly philosophical manners. Since leaving the agency in April, he has joined the board of Pfizer and, most recently, the board of Aetion, a healthcare technology company that delivers RWE for life sciences companies, payers, and regulatory agencies.

Author: Michael Causey