Mike Buckley, MSK’s Associate Director of Product, Clinical Research Informatics & Technology (CRIT)
The global clinical research community is facing a clear imperative to move beyond traditional manual data management methods in order to improve data capture, integrity, and exchange, while pursuing other related efficiencies.
Memorial Sloan Kettering Cancer Center (MSK) has been a leader in this movement. “We work closely with our peers in academia, biopharma, consortia, and the FDA to solve existing challenges and explore novel opportunities in research data interoperability,” says Mike Buckley, MSK’s Associate Director of Product, Clinical Research Informatics & Technology (CRIT).
“One of our key priorities,” he explains, “is to accelerate and scale the use of the HL7® FHIR® standard,” This refers to the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®), a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information to support clinical practice, including delivery of health services.
During Q4 2024, Mr. Buckley presented MSK results from a real-world mirror study of the impact of electronic health record (EHR) to electronic data capture (EDC) technology to the U.S. FDA Center for Drug Evaluation & Research (CDER) Health IT Board.
The study measured the impact of EHR-to-EDC technology in a time-controlled real-world scenario using five investigator-initiated trials. Investigators tracked the time and productivity of data managers from five different oncology services performing one hour of manual data entry compared with one hour of electronic data entry using technology designed by IgniteData, in collaboration with the MSK Innovation Hub (MSK iHub).
Overall, the EHR to EDC technology reduced data entry errors by 99%. Significantly, it increased productivity, compared to manual data management methods, by 58%.
MSK’s recent presentation is a part of a process that has been ongoing since 2016, aimed at keeping the FDA’s CDER Health IT Board updated on clinical research initiatives to drive and scale the use of the HL7® FHIR® protocol.
“We are committed to using HL7® FHIR® as part of our larger effort to achieve meaningful improvements in how clinical trial data is managed and communicated,” says Mr. Buckley, who is the Co-Founder and 2017 Co-Chair of the Society for Clinical Data Management eSource Implementation Consortium, and a Steering Committee Member of the HL7® Vulcan Accelerator program founded in 2019.
Learn more about how the activities of the MSK CRIT team bring innovation benefits to industry sponsors and regulators and foster clinical research innovation globally. For additional background on the global drive to improve clinical research data management, see here: