What role can electronic health record data play in clinical research? That's a huge topic that health IT policymakers must grapple with in the planning stages of a national health information network.
Obviously, having medical records in electronic form holds out great potential for researchers, and it also seems obvious that making data available for clinical research fits squarely within the definition of meaningful use. But because until now EHR systems have not been developed with clinical research in mind, extracting data for use in trials has proved a challenge.
Although approximately $100 billion is spent annually on medical research in the U.S., standards have not yet been developed for the exchange of data between EHRs and clinical research management systems.
Researchers face other administrative headaches as well. Sixty percent of trials data is still gathered on paper, and even sites that have clinical research IT systems usually face difficulties sharing that data with collaborators on multi-site studies. Often, they must double-enter data into multiple systems. Then they must cope with trying to automate the process of billing insurers for clinical services related to research. This administrative burden may discourage clinicians from participating in research projects.
During an Oct. 21 National eHealth Collaborative meeting, Daniel Ford, MD, MPH, vice dean of clinical investigation at Johns Hopkins University in Baltimore, said that although the promise of health IT is great, a recent survey of academic medical centers found a majority do not feel they are getting important information from EHRs yet.
Ford added that it's important that clinical research have a voice in the design and selection of IT systems at medical centers involved in research. He said both patients and research staff have shown some ambivalence toward integrated research-clinical systems. In other words, they see some privacy risks, but the benefits seem abstract at this point. He believes it's essential that there be some early demonstrations of the value of integrated IT solutions for advancing knowledge.
There is some progress being made on standards. Gregory Downing, DO, PhD, the director of the Personalized Health Care Initiative for the U.S. Department of Health and Human Services, noted that with support from the Office of the National Coordinator for Health IT, ANSI has convened an EHR Clinical Research Workgroup to prioritize clinical research capabilities for HITSP harmonization. The group is identifying a common set of core research data elements that can readily be exchanged between EHRs and clinical research systems, Downing added.
CCHIT also has a Clinical Research Work Group working on recommendations of optional criteria and test scripts that other certification categories could use to address the needs of clinical researchers.
As Daniel Castro of the Information Technology and Innovation Foundation recommends in a recently published paper, HHS must consider the importance of the secondary use of medical data as its definition of meaningful use evolves, and allocate funds accordingly.
Castro notes that the U.K.'s National Health Service has emphasized medical research as one of its core missions, while "the United States currently lacks the capacity being developed by the NHS to turn its existing or future electronic health records into a usable database for medical research," he writes. "To benefit from the full potential of health informatics, the United States should develop the capability to share medical data for authorized research in a timely and efficient manner."
Is a national data-sharing infrastructure for clinical research a possibility or a pipe dream? What other issues does the concept raise?