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# FDA Expanding RWD/RWE Use: Marston
- URL: https://www.fdaweb.com/fda-expanding-rwd-rwe-use-marston/
- Published: 2024-08-27T12:00:00.000Z
- Updated: 2026-09-14T14:39:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157661

FDA has several ongoing initiatives related to real-world data and real-world evidence in what has become a dynamic space. That’s the word from FDA chief medical officer **Hilary Marston**, speaking on a recent “Q&A with FDA” [podcast](https://www.fda.gov/drugs/news-events-human-drugs/real-world-data-and-evidence-generation-dr-hilary-marston?ref=fdaweb.com).

“We’ve expanded our use of real-world data in the postmarket space,” Marston said. “We’ve been using real-world data in the postmarket space for some time to monitor and evaluate the safety of approved drugs. But that’s expanded with systems like our Sentinel System \[that\] uses electronic health data, such as medical claims and pharmacy dispensing data, to execute some of our pharmacoepidemiologic queries and studies.”

Asked about challenges in collecting real-world data for postmarket assessment of drug safety and efficacy, Marston said the postmarket phase often fails to address questions that can only be addressed in the clinical practice setting. She said such questions are often left unanswered because of a separation between clinical practice and clinical research. “What we need here is an evidence-generation ecosystem that could help to overcome the challenges that are inhibiting collaboration,” she said…. “FDA is doing its part to support this sort of innovation, whether it’s through recent guidances that we’ve published and just finalized, the decentralized trials guidance, or dedicated programs like the newly-launched CDER Center for Clinical Trial Innovation.”

Marston indicated that the agency is capable of reviewing submissions that include or even rely entirely on real-world data. “FDA has already accepted real-world evidence to support drug and medical device product approvals. Many of these are in the setting of oncology and rare diseases. Looking forward, we’re focused on not only promoting inclusion of real-world data used to generate real-world evidence in submissions, but internally we’re ensuring consistency in our reviews of these submissions, and working with a variety of federal and external partners to help put in place an ‘evidence-ready’ system.”