Over the last few years, the clinical research industry has increasingly adopted electronic data capture (EDC), embracing technology into the clinical trials process.
But while the FDA has remained ambiguous about whether a source document can come from a computer rather than a piece of paper, sponsors have asked sites to do both—record the patient history and details from visits by hand on paper, then turn around and enter it all into an EDC system.
Naturally, this has doubled the work load at the site level and also created extra work for CROs and sponsors, which have to spend time—and money—on source document verification.
But it doesn’t have to be this way, said Ed Seguine, president of Clinical Ink, a startup that has developed a data-capture tool he describes as the first clinical-trial application for source documentation that runs on tablet PCs. Picture an iPad-sized PC that offers source documentation forms that look exactly like the paper forms site staff are used to, with a pen that uses handwriting recognition. It’s called SureSource.
Seguine said study coordinators load the patient history and site visit information right into the tablet PC. Instead of saving and sending after each question is answered, as is done with most EDC, the system saves all data every 30 seconds. It’s both on and off line, so if Internet access is interrupted data is not lost, said Seguine, adding that no training is required. And the system allows room for contextual notes, unlike most EDCs.
“If a coordinator wants to make a note that ‘The subject’s blood pressure was high because he just ran in from the car,’ EDC would just say ‘This is out of range,’” said Seguine. This feature allows for far more context and data quality, he said. And all data are validated at time of capture.
Clinical Ink is marketing SureSource to sponsors and CROs and, if adopted, the technology could save the industry millions and reduce redundancies at sites, freeing them to spend more time seeing patients and recruiting, Seguine said.
Clinical Ink is the brain child of Thomas Littlejohn, president and executive medical director of Winston-Salem, N.C.-based site group PMG Research. Littlejohn brought on Seguine, who had been general manager of Medidata Solutions’ trial planning group after it acquired Fast Track, of which Seguine was CEO. For the two and a half years SureSource has been under development, said Seguine, PMG’s 11 sites have served as a captive user group to test whether the application met the work-process needs of a site. The technology is also being piloted at Ohio State University.
The FDA released a draft guidance on the matter in December 2010, providing a bit more detail on what can be a source document and indicating greater acceptance of eSource documents, which are parts of the case report that have originated at a computer. That was good timing for Clinical Ink.
In addition to saving sites time by eliminating the need to transcribe, and saving sponsors and CROs money in source document verification, Seguine said the technology could save money in monitoring costs, too.
“If you capture all these formerly paper forms stuck at the site, and instead capture them and post them directly to a website, monitors can now sit at home and monitor the study,” he said. “There will still be a degree of travel needed, to do things like evaluate conditions at the site and make sure consent is appropriate. But you’ll be able to dramatically reduce the amount of travel.”
Clinical Ink has not yet sold any products since they became available last summer, but Seguine said a number of sponsors and CROs are showing interest. Arnold Adriaanse, CEO of standalone, Tucson, Az., site Genova Clinical Research, said he’s looking forward to Clinical Ink’s wares being adopted.
“We haven’t found anything that looks like it,” he said. “They are bridging the huge gap between collecting data during patient visits and having to put them in eCRF systems.”
Adriaanse has run the numbers at his site, and knows that 60% of his coordinators’ time is spent transcribing data from paper source documents to eCRF. In fact, his site stops seeing patients at 2 p.m. each day so the coordinators can turn their attention to transcribing. He’s excited that Clinical Ink’s technology eliminates the eCRF step all together.
“I can’t imagine that once sponsors learn about this that they won’t go for it,” said Adriaanse. “They’re paying billions of dollars in source data verification. Even if you eliminate just half of the work that’s being done, it will be a great gain.”
— Suz Redfearn