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# FDA Quality Guide on Real World Data Coming
- URL: https://www.fdaweb.com/fda-quality-guide-on-real-world-data-coming/
- Published: 2019-09-09T12:00:00.000Z
- Updated: 2026-09-15T01:48:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144948

FDA saysit is developing guidance on data quality issues that pertain to real world data and related study design considerations. Writing in a 9/6 *Clinical Journal of the American Society of Nephrology* [*perspective piece*](https://cjasn.asnjournals.org/content/clinjasn/early/2019/09/05/CJN.02790319.full.pdf?ref=fdaweb.com)*, two CDER* Division of Cardiovascular and Renal Products officials, **Aliza M. Thompson** and **Mary Ross Southworth**, say the most promising use of real world data to support effectiveness determinations is the “integration of randomized clinical trials into conventional health care systems. Such trials could use data collected from electronic health records, laboratory or claims data, or emerging technology (actigraphy and mobile applications) to assess study outcomes or otherwise streamline the conduct of the trial (e.g., by facilitating recruitment and enrollment).”

The CDER officials note that a lot of work remains to ensure that the data are sufficiently reliable, complete, and high quality, but the “approach holds promise for improving patient recruitment and retention, decreasing burden on study participants, increasing study efficiency, and possibly, better ensuring that trial populations are more representative of the populations likely to use a drug in clinical practice.”

Additionally, the article touches on several key concepts that have emerged in discussions with stakeholders about the use of real world evidence to support regulatory decisions. “One is the importance of ensuring sufficient data quality to enable reliable decisions, recognizing that it may be difficult for real world data to meet the same standards as data collected in traditional clinical trials,” it says. “Another is the need to gain a better understanding of the study designs and analytic approaches using real world evidence that are most likely to provide the level of certainty and scientific rigor needed to address regulatory questions.”

And there are potential barriers to using electronic health records and insurance claims data as sources of real world data, the officials write. “These include lack of system interoperability and data standardization, missing information on important confounders (smoking, body mass index, and degree of kidney impairment), and concerns about privacy,” they say. “There is also widespread recognition that there will be a learning curve and that stakeholder engagement and demonstration projects will be critical.”