Guest: Landen Bain, CDISC
February 25, 2009
In 2009, it is easier and more feasible to connect two vast data cosmos that have long existed separately. The electronic data capture (EDC) systems for clinical research are slowly being connected to larger, more general-purpose electronic health record (EHR) systems for physicians.
The integration of EHR and EDC technologies has long been theorized. But today it is being driven by evangelists who remain chagrined by the mammoth inefficiencies of manually moving data between purportedly “sophisticated” systems.
Multiple factors are fueling the shift. EDC suppliers such as Outcome, Phoenix Data Systems and Nextrials have demonstrated systems that can connect to EHRs. In the other direction, EHR firms like Siemens, Cerner and Allscripts have connected their systems to those used in pharmaceutical research. Both types of companies know that the possibility of rewards from participating in industry-sponsored projects might entice doctors to buy or recommend their systems.
Then there’s Barack Obama’s plan to spend $19 billion on subsidies to entice doctors and hospitals to buy EHRs. That’s a 1,000-fold increase over funding levels that the U.S. Congress had previously considered and rejected. The cash will mean that whatever the usage of EHRs is now, it will soon be radically different.
No one is better equipped to say exactly how EHR and EDC systems should come together than Landen Bain, health care liaison at the Clinical Data Interchange Standards Consortium (CDISC). Bain’s recent projects for CDISC, as well as trade show demonstrations, suggest a clear, logical way to connect EHR and EDC systems.
The CDISC roadmap has been developed in consultation with standards organizations and the FDA. The roadmap makes sense in business and regulatory terms. As this 14-minute audio interview explains, the EHR and EDC systems would each operate as they do now—but pass data and forms back and forth. The key point is that such exchanges will not impair either system’s ability to comply with separate bodies of regulation applying to the EHR and EDC industries.
If such linkages can progress, the returns on investment would be dramatic. For starters, EHR systems could load significant quantities of demographic data automatically, reducing the need for sites to laboriously enter data twice. That could have broad effects on the relationships between sponsors and sites. Lighter obligations and higher rewards for clinical research could encourage more sites to participate.
Beyond those efficiencies, there are also hypothetical public health aspects to the EHR-EDC linkage. There is a potential to expedite the identification or confirmation of drug safety issues. Some of the earliest public scientific signals about Vioxx came not from FDA, not from its manufacturer, but from the Kaiser EHR system. In part, as Bain explains on our podcast, future insights of that sort may be understood as a digital adaptation of an ancient agricultural practice called gleaning.