Real World Evidence: FDA Commits to Advancing its Use

Posted 19 September 2017 By Zachary Brennan


To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

"We need to close the evidence gap between the information we use to make FDA's decisions and the evidence increasingly used by the medical community, by payers, and by others charged with making healthcare decisions," Gottlieb told attendees of the National Academy of Sciences' workshop on the impact of RWE on medical product development.

The comments follow FDA's recent finalization of guidance for medical device manufacturers on the use of RWE. In addition, FDA has said the use of RWE could help expand certain labels for oncology treatments.

While noting the current uncertainty among sponsors on the role RWE plays in regulatory decision making, Gottlieb said FDA needs to think of itself as an information curator, rather than an arbiter of information, "where a single truth standard is secured to a fixed orthodoxy."

Electronic medical records often are structured in ways that are geared toward billing, Gottlieb said, noting that clinically relevant information is often retained in unstructured notes.

"Ideally, we'd like to have a system where providers have the right incentives to enter clinically relevant information into EMRs at the point of care," he added.

In the Q&A portion of the talk, former FDA Commissioner Robert Califf (who previously made RWE his "top programmatic priority"), following a funny discussion of he and Gottlieb's use Twitter and how they were both advised not to use the platform, though Gottlieb said he dismissed the lawyers, said that he believes FDA needs to be proactive in breaking the logjam on the use of RWE and digging more into "what patients care about."

Rachel Sherman, principal deputy commissioner at FDA, added later in the day: "We want a better evidence base to make product approval decisions" and she noted that more guidance will be forthcoming on RWE and real world data (RWD).

"The goal is not to define RWE and RWD but to get better information and in a more sensible way," she added.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, News, US, FDA

Tags: real world evidence, Scott Gottlieb, clinical data

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