Standards organization Health Level Seven International, better known as HL7, is working with the National Cancer Institute (NCI) to facilitate the delivery of clinical trial data to clinicians via their electronic health records (EHRs). The effort will use HL7's Clinical Document Architecture (CDA), which is also the foundation of the clinical summary that the Centers for Medicare & Medicaid Services (CMS) proposes to use in the 2014 edition of certified EHR technology.
"Studies have shown that right now it can take seven years or more for new research advances to be put into clinical practice," Robert Dolin, MD, vice chair of the HL7 board of directors said in an announcement. "We can make that process much quicker by improving physician access to clinical trial data, and by expressing clinical trial data using meaningful use EHR standards."
When the new system is available, "physicians will have a more complete picture of the care provided to their patients during clinical trials, and the project will also help facilitate data analysis that may speed the availability of new treatments to patients," according to the announcement.
HL7 and NCI have already shown that clinical trial data can be packaged within the same HL7 standards that EHRs certified for Stage 1 Meaningful Use already incorporate. A pilot of the technology needed to link the two kinds of data will be conducted later this year, HL7 said. Ekagra Software Technologies and Lantana Consulting Group helped develop this technology.
The HL7 CDA supports the exchange of clinical documents between providers involved in the care of patients. It also allows for the re-use of clinical data for public health reporting, quality monitoring, patient safety and clinical trials, according to HL7.
Up to now, the software used to identify patients for clinical trials and document the studies has been totally separate from EHRs. Not only do the two kinds of applications have different databases, but EHRs were also not designed for clinical research. However, Oracle recently introduced a data warehouse and analytics system that's designed to assimilate data from disparate EHRs and other sources and meld the information into a usable research database, according to an InformationWeek article.
Meanwhile, other efforts are underway to link EHRs to clinical research. The Partnership to Advance Clinical Electronic Research (PACeR)--a consortium of medical research centers, pharmaceutical firms, advocacy groups and health IT organizations--plans to work with institutions across New York State to incorporate a standard set of research data into each institution's EHR. And the Clinical Data Interchange Consortium (CDISC) has defined the use of EHRs to capture clinical trial data and incorporated that into an HL7 functional model.