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# FDA Urged to Expand Real-World Data Use
- URL: https://www.fdaweb.com/fda-urged-to-expand-real-world-data-use/
- Published: 2025-07-08T12:00:00.000Z
- Updated: 2026-09-14T15:15:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159470

FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of approved medical products, a move that would augment data from initial clinical trials according to Ethics and Public Policy Center physician and bioethicist **Aaron Kheriaty**. Writing in an [opinion piece](https://thehill.com/opinion/healthcare/5376764-fda-should-make-decisions-based-on-what-drugs-do-in-real-life-not-just-company-trials/?ref=fdaweb.com) in *The Hill*, he urges the agency to intensify its use of health insurance claims, electronic medical records, and other large-scale clinical databases to detect adverse drug effects that may not be evident during the controlled, pre-approval clinical trial phase.

“Clinical trials are essential, but they are conducted in artificial settings with limited populations,” says Kheriaty. “Once a drug is on the market, we need to see how it performs in the complexity of real-world medicine, where patients have coexisting conditions, take multiple medications, and vary widely in age, race, and other factors.”

Kheriaty points to historical examples where real-world data played a pivotal role in identifying previously undetected risks. Among them is the painkiller Vioxx (rofecoxib), which was withdrawn from the market in 2004 after post-market data revealed increased risks of heart attacks and strokes — signals that were missed in earlier clinical trials involving healthier, lower-risk patients. He also cites FDA’s 2004 decision to add a black box warning about suicidality risks to SSRI antidepressants for adolescents and young adults, a change informed by post-marketing data.

Some critics argue that randomized controlled trials remain the gold standard for assessing drug efficacy and causality, but Kheriaty notes that real-world studies — when conducted with rigorous statistical techniques such as propensity score matching or instrumental variable analysis — can offer complementary insights that are essential for a full drug evaluation. “Every study design has limitations,” he writes. “But by combining data sources and methodologies, we improve our ability to make evidence-based regulatory decisions.”