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# FDA Officials Discuss Real-world Data/Evidence
- URL: https://www.fdaweb.com/fda-officials-discuss-real-world-data-evidence/
- Published: 2020-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:04:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146156

In a new post on FDA’s Web site, two senior CDER officials discuss how real world data (RWD) and real world evidence (RWE) can be used in making regulatory decisions. “RWD, according to the FDA’s definition, are data that are routinely collected about a patient's health status, including data that the doctor is recording during an office visit, information submitted to an insurer, and data from product and disease registries,” says CDER Office of Medical Policy director **Jacqueline Corrigan-Curay** in the [post](https://www.fda.gov/drugs/news-events-human-drugs/real-world-evidence-safety-potential-tool-advancing-innovative-ways-develop-new-medical-therapies?ref=fdaweb.com). “RWD can also be data that are collected outside the health care setting — for instance, data from mobile technologies, including wearables and sensors that gather information on our movements and what we're doing, as well as data from social media platforms.”

This kind of RWD has the potential to be used to generate scientific evidence that the agency can use to make decisions about the safety and effectiveness of medical products — “such as finding new safety issues with a drug after it is approved and on the market or helping to determine the effectiveness of a drug for a new indication,” Corrigan-Curay says. She notes that RWD potentially being used for effectiveness assessments is still under evaluation and CDER is developing a guidance on its role in doing this.

Corrigan-Curay says that a clinical trial can generate RWE by using RWD in clinical practice to assess study outcomes. “By integrating a clinical trial into the setting where patients receive their clinical care, sponsors can both randomly assign participants and capture relevant clinical endpoints from the records of their clinical care,” she explains. Such trials can also use digital technologies to capture data on patients on a daily basis, she says.

CDER associate director for real world evidence analytics **David Martin** explains in the post that when randomized controlled clinical trials are not feasible, other uses of RWD to generate RWE could be used. “Researchers seeking to study drugs to treat serious rare diseases and some types of cancer may run into difficulty trying to design randomized controlled clinical trials because they cannot find enough people for a trial or there is no available comparison drug to use in a second arm (and patients are reluctant to enter a trial with a no-treatment \[placebo\] arm),” he says. “In a case like this, researchers might find medical records of similar patients who did not receive the investigational drug and compare these patients to research participants in the trial who received the investigational drug. With electronic medical records, it may be easier to generate such external controls when appropriate.”

Corrigan-Curay says RWE to establish effectiveness is still an emerging science, but there are several examples where historical controls were derived from RWD. The posting offers several examples of these. She adds that disease registries have been another source of RWD because they capture clinical outcomes of a defined population of patients.

“If RWE evolves as an accurate assessment of effectiveness in certain clinical cases,” Corrigan-Curay says, “then its role in supporting approvals for new indications for drugs already on the market will grow more robust. It also will continue to highlight potential safety issues in approved drugs and potentially be used as a hybrid with clinical trials. And as the FDA uses RWE studies in its decision-making process, more companies may be likely to conduct RWE analyses, strengthening this area of research.”