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RWE Alliance Commends FDA Draft Guidance for EHR Data Use

The RWE Alliance commended FDA’s draft guidance on the use of EHR data to support regulatory review of medical products.

The RWE Alliance has submitted a comment letter in response to the FDA draft guidance on using medical claims and EHR data for real world evidence (RWE) to support regulatory decision making.

The RWE Alliance commended the draft guidance and gave several recommendations on how FDA can adjust the final guidance to enhance confidence in RWE study results.

In particular, RWE Alliance officials suggested that FDA state more clearly in the final guidance that different approaches to RWE studies can be appropriate in specific use cases, depending on the circumstances.

Additionally, they called on FDA to provide recommendations for successful use of real-world data curated from more than one source, such as EHR data and medical claims information.

“FDA’s draft guidance for using EHRs and medical claims data in regulatory decision making represents a key step on our journey toward standardized methods for evaluating and analyzing RWD,” Jeremy Rassen, co-founder and president at Aetion, noted in a press release.  

“These methods are a necessary component of high-quality and credible RWE, and the level of detail in the guidance signals FDA’s commitment to advancing the use of EHR and claims data in product submissions,” he added. “We are pleased to share our experience and insights with the Agency as it works to finalize the guidance.”

RWE Alliance’s comment letter also called on FDA to address the distinctions between medical claims and EHR data and differentiate the recommendations for these two data sources in the final guidance.

In addition, officials suggested FDA clarify that the appropriate approach to outcome validation in a specific use case will be dependent on the study.  

Lastly, the RWE Alliance recommended the agency consider increased communication with external stakeholders about concrete RWE use cases.

“We continue to appreciate FDA’s commitment to expanding the scope of data considered in regulatory decision making,” said Rob Kotchie, president of Real World Solutions at IQVIA. “With the recent draft guidance surrounding the use of EHRs and medical claims data, FDA is taking an additional important step in its use of RWE.”

“As a founding member of the RWE Alliance, IQVIA is committed to advancing the FDA effort through responses to the draft guidance that promote the use of RWE for the benefit of patients,” Kotchie continued.

Lauren Silvis, senior vice president for external affairs at Tempus, emphasized that the inclusion of RWE in regulatory decision making is essential to advancing medical product innovation.

“We look forward to ongoing engagement with FDA to help advance the use of high-quality data from diverse real-world sources,” she noted.

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