By Deb Borfitz
March 16, 2009 | Last summer, Nextrials joined the quest by the Clinical Data Interchange Standards Consortium (CDISC) to facilitate the integration of electronic data capture (EDC) technology and electronic health records (EHR) platforms. But it may accomplish more, and sooner, with its own entrepreneurial wit.
The CDISC effort is focused on calling up an EDC data entry screen, pre-populated with routine patient information, like demographics and medical history, from within a standard EHR environment. A demonstration of this capability took place last month at the 10th Annual North America Connectathon in Chicago, sponsored by Integrating the Healthcare Enterprise (IHE). (The demo will be repeated at the interoperability showcase of the Healthcare Information and Management Systems Society conference April 4-8 in the same city. CDISC will do a similar showcase at the DIA meeting this June in San Diego.)
This was Nextrials’ first Connectathon. Outcome Sciences was the first EDC vendor to join the cause two years ago. Phoenix Data Systems made a last-minute scramble to participate in this year’s event. Phase Forward, which played a “peripheral role” at last year’s Connectathon by receiving data into its clinical database management system, was absent, says Nextrials CEO James Rogers.
IHE’s enabling Retrieve Form for Data Capture (RFD) is “somewhere between an emerging and established standard,” says Rogers. Its new Clinical Research Data Capture (CRD) standard, addressing pre-populating that form with patient data, is groundbreaking.
The integration push has elicited fears that EHR could supersede the need for EDC. “The time horizon for that…is pretty far away and there’ll always be a large number of studies that need to be done outside of large institutions at clinics that don’t have EHR enabled for this purpose,” says Rogers. The way he sees it, integration tools will help keep EDC relevant.
Rogers is positioning Nextrials to be one of the integration leaders. Externally, Nextrials recently became one of the charter members pledging support for the American National Standards Institute’s initiative to facilitate the use of electronic health information within global clinical research activities. Internally, the company is creating linkages to assist with data queries and enrollment, neither of which EHR systems are currently set up to do.
“My original goal was to have one pilot initiated by the end of 2009 and we have already started up on two pilots,” says Rogers. Both are investigator-initiated trials with Greenway Medical Technologies involving pre-populating Prism, Nextrials’ flagship EDC system, with EHR data. One study is a prospective trial with new patients and trial data entered along with retrospective information. That makes Nextrials the second company, after Outcome Sciences, to implement the RFD standard on an actual study and the first to implement the standard on a multi-site study.
“Big pharma is very interested in this,” says Rogers, adding that linkages between Prism and EHR systems will give Nextrials a competitive advantage over any EDC vendor that fails to follow suit. “The big beneficiaries are sites because they won’t have to learn a new system. Integration means less work per patient.”
But the demand for integration will come from sponsor companies who want data faster and cheaper. “If they can get data directly out of an EHR, they won’t need source data verification,” says Rogers. “That would cut way back on monitoring visits.”
Nextrials is now in discussions with a large pharmaceutical company interested in using Prism to pre-populate post-marketing forms with EHR data so sites are more likely to spontaneously record adverse events. “We see a business need out there that’s real and immediate,” says Rogers, adding that he expects the up tick in activity to have a positive impact on the company’s bottom line.