Four major pharmaceutical companies and a California systems integration services firm are providing the "brain and brawn" -- as well as the funding – to demonstrate the feasibility of integrating data capture needs of clinical research and disease prevention with electronic health records (EHRs), says Tanyss Mason, director of communications for the Clinical Data Interchange Standards Consortium (CDISC). At present, "it's not unusual for [investigative] sites to have an EHR as well as multiple EDC [electronic data capture] tools, and it's unwieldy."
CDISC, which is spearheading the demonstration project, views data capture as a "single-source encounter between an investigator/physician and subject/patient," says Landen Bain, CDISC liaison to healthcare. The "key idea" is to have a data-capture form appear on the computer screen in an EHR session. "If you have an EHR, it's contorted to go to a different computer and a different application to enter data for a clinical trial when the data originates inside the EHR and that's where you do [most of] your work."
The collaborative project has five different "scenarios," each representing a different aspect of connectivity, says Mason. The clinical trial execution scenario uses Cerner's EHR to fill out and return a case report form retrieved from Lilly. The scenario for disease or patient registries involves an Allscripts user working in a similar fashion with a data-capture form from Outcome, the EDC agent for Genzyme.
The bio-surveillance scenario, sponsored by San Diego-based Science Applications International Corporation (SAIC), has an Allscripts user fill out an onscreen form about a disease outbreak and send it to the Centers for Disease Control and Prevention. The user is prompted by "flags and triggers identified during the data entry process," says Mason.
The post-marketing safety surveillance scenario likewise uses Allscripts' EHR, but as the means to fetch a form from Pfizer to report a suspected adverse event, continues Mason. The scenario for clinical trial laboratory data has a Siemens' EHR user receiving and completing a form from Novartis for requested lab tests (and possibly radiology images).
The common theme, says Bain, is an easy-to-use "integration profile" called Retrieve Form for Data-capture (RFD) that was co-developed by CDISC and Integrating the Healthcare Enterprise (IHE), a healthcare interoperability enabler. "The EHR is the retriever." The RFD creates a "scenario for connectivity that in the real world makes sense to real people." It's a bit like a "cookbook" that provides a different mix of standards for different data collection occasions, such as clinical research or public safety.
Different versions of the RFD, created for each of the five scenarios, can be seen in action at CDISC's "New Directions" life sciences demonstration of the HIMSS (Health Information Management Systems Society) Interoperability Showcase. The showcase is part of the annual HIMSS conference and trade show February 25 to March 1 in New Orleans. The dress rehearsal takes place a month earlier at a Connectathon in Chicago, which Bain describes as "a giant geek fest for techies."
If all goes well, CDISC plans to take its show on the road, possibly to the annual Drug Information Association meeting and CDISC interchange meetings in the U.S. and abroad, says Mason.
Real-world integration will occur once investigative sites, as customers of EHR, start to specifically request an interface for clinical trial data capture as a system feature, says Bain. Those customers will be among the 20,000-30,000 people expected to attend the upcoming HIMSS conference. "There's a lot of latent market demand [for integration] out there."
The other possibility is that pharmaceutical companies will push EDC vendors to make their data-capture forms compliant with CDISC's ODM (Operational Data Model) standard and available for use with a technology called Xforms, as Outcome has done. That's what makes it possible for the EHR to respond to requests for research-related forms, says Bain.
Deborah Borfitz, is a Vero Beach, Fla.-based freelance writer who previously contributed to the clinical trials publication CenterWatch. She is co-author of Informed Consent, covering the risks and benefits of volunteering for trials. She also writes extensively about healthcare trends, marketing, business development, and Internet intelligence.