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# Comments on Real-World Data Guidance
- URL: https://www.fdaweb.com/comments-on-real-world-data-guidance/
- Published: 2022-01-25T12:00:00.000Z
- Updated: 2026-09-14T17:29:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151000

Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for releasing a draft guidance, *Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products*, that gives key principles on the reliability and use of relevant data from electronic health records and medical claims data to be used for regulatory decision-making. The association’s 1/24 comment [letter](https://downloads.regulations.gov/FDA-2020-D-2307-0063/attachment%5F1.pdf?ref=fdaweb.com) says more specific guidance is needed to help enable sponsors and data providers to generate consistent assessment reports for data quality that will meet FDA’s needs.

“PhRMA proposes that industry and data providers could work with the agency to develop such a framework,” the letter says. “FDA could then include the framework of data quality metrics in an appendix to the final guidance that outlines key elements to include in regulatory submissions.”

In its [comment](https://downloads.regulations.gov/FDA-2020-D-2307-0061/attachment%5F1.pdf?ref=fdaweb.com), the Duke-Margolis Center for Health Policy says it is pleased by the thoroughness of the draft guidance despite the complex topics under consideration. Its comments cover **(1)** highlighting the unique strengths and limitations of electronic health record data and claims data, alone and combined; **(2)** developing resources and convenings to advance data validation approaches and expand on the concept of verification; **(3)** considering implementing a risk-based approach to validation and verification of data elements; **(4)** clarifying recommendations for evaluating missing data; and **(5)** collaborating with a broad range of stakeholders to ensure responsible and meaningful data linkage.

The center suggests these action items as near-term steps for FDA and other stakeholders to consider as the guidance is revised and implemented: 

- FDA support for convenings on the topic of data quality to promote alignment between FDA, sponsors, and data curators on appropriate data quality benchmarks and standards;
- sponsor and data curator collaboration to develop standard operating procedures that offer transparency around data curation approaches;
- FDA identification of analytical tools and strategies deemed acceptable to the agency to address bias and confounding due to missing data or misclassification of data; and
- FDA support for convenings to build consensus on what constitutes acceptable quality for combining data from multiple sources and strategies that can address issues and complexities associated with using data linkage to address missing data.

The Biotechnology Innovation Organization [says](https://downloads.regulations.gov/FDA-2020-D-2307-0055/attachment%5F1.pdf?ref=fdaweb.com) that overall the guidance “provides sponsors with helpful clarifications about the agency’s expectations for providing high-quality real-world data that are reliable and relevant for various types of clinical studies.” The association’s three major recommendations are: 

- incorporate an appropriate degree of regulatory flexibility;
- identify streamlined and efficient FDA-sponsor communication methods to facilitate rapid evidence generation; and
- identify best practices for data curation, processing, and governance.

Finally, the National Center for Health Research [says](https://www.regulations.gov/comment/FDA-2020-D-2307-0058?ref=fdaweb.com) it has concerns about the limitations of various data sources and raises three issues for FDA consideration in the final guidance.