Austin, TX, 30 October 2025 – A newly published study in Alzheimer’s & Dementia demonstrates the critical role of data standards in advancing Alzheimer’s disease and related dementias (ADRD) research. The study compared alignment between the Alzheimer’s Disease Research Centers (ADRC) Uniform Data Set (UDS), HL7® Fast Healthcare Interoperability Resources (FHIR), and Clinical Data Interchange Standards Consortium (CDISC) standards.
The findings reveal that 45% of UDS data elements mapped to FHIR, indicating the potential for leveraging electronic health records (EHRs) in research. Data elements mapped to CDISC standards at a rate of 94%, underscoring their robust compatibility with industry and regulatory needs.
“This research underscores that CDISC standards can provide a foundation for capturing and structuring Alzheimer’s research data while also complementing healthcare standards like HL7 FHIR,” said Bess LeRoy, Head of Data Standards Development at CDISC. “Together, CDISC and HL7 can enable researchers to bridge clinical care and research, accelerating the use of real-world data to improve patient outcomes.”
The study highlights how these two standards serve distinct but complementary roles. CDISC provides a comprehensive framework for clinical research data throughout the entire study lifecycle, from protocol through analysis results, while HL7 FHIR serves as a crucial conduit for accessing real-world data from electronic health records and other clinical care systems. Together, they enable seamless integration of real-world evidence into clinical research, with FHIR providing the standardized interface to capture patient data from routine care settings that can then be transformed into CDISC formats for research analysis and regulatory reporting.
By mapping ADRC UDS data to both frameworks, the research demonstrates the feasibility of harmonization for data elements, paving the way for improved data reuse, reduced trial costs, and stronger evidence generation from real-world data sources.
“The Alzheimer’s Association strongly supports data harmonization efforts because they are essential for speeding up innovation and efficiency in research about Alzheimer’s and all other diseases that cause dementia,” said Heather M. Snyder, Ph.D., Alzheimer’s Association Senior Vice President of Medical and Scientific Relations. “While data harmonization can be a complex challenge, it enables larger, more powerful analyses and thus has the potential to lead to more precise estimates of disease effects, better understanding of health disparities, and faster discovery of new prevention and treatment strategies.”
This study represents an important step toward realizing the vision of a fully interoperable research and healthcare data environment. By ensuring compatibility between FHIR and CDISC, researchers and industry stakeholders can accelerate innovation not only in Alzheimer’s research, but across other therapeutic areas.
The full article, “Measuring alignment between the ADRC UDS data elements, FDA, and EHR data standards” is available in Alzheimer’s & Dementia [DOI: 10.1002/alz.70628].
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)3 global nonprofit charitable organization with thousands of partners, volunteers, and member organizations around the world.
