By Deb Borfitz
April 6, 2009 | Frustrated by electronic data capture (EDC) systems designed more for data managers than clinical investigators and trial site personnel, Clinical Ink set out more than three years ago to develop a solution more to its liking. The result was a “game changing” data-capture tool known as SureSource that is now undergoing pilot testing by Clinical Research Management (CRMi), a Springfield, Mass.-based clinical research organization and Everett Clinical Research Systems, a Toronto, Canada-based data management company.
Clinical Ink is a spin-off of Piedmont Medical Group (PMG), an independent, ten-site investigative network based in Winston-Salem, N.C. that has about 350 clinical trials running at any one time. PMG has used dozens of EDC systems, all of which have proven difficult to use and “counter-intuitive to health care,” according to Tommy Littlejohn, III, president of PMG and Clinical Ink. They also inadvertently lower the accountability of principal investigators (PIs) for data quality.
SureSource eliminates the case report form step altogether, says Littlejohn. Protocol-specific source documents are created and deployed to sites on tablet PCs, which can work either connected or disconnected from the Internet. Study coordinators use SureSource to document study visits, adverse events, and concomitant medications with familiar strokes of a pen. Data entry fields are included to capture required data, such as blood pressure or drug dispensation. Handwritten comments can also be added on the fly anywhere on the forms.
|Tommy Littlejohn, III
With SureSource, unlike traditional EDC tools, study data get recorded only once and are virtually error-free, as all data are validated at time of capture, says Littlejohn. When PIs write their signature on the tablet, it’s the last time they have to sign off on that data.
Minutes after the data are captured, they can be delivered to a secure web portal, from which both machine-readable information and handwritten comments and signatures are available to authorized study monitors, regulators, and data managers. The data also get passed onto the sponsor’s data management system for analysis, “in the same state it would have been in coming out of an EDC system—complete and validated.”
As SureSource is electronic and “lives on the web,” monitoring visits to validate data become superfluous, says Littlejohn. “We think we can cut the number of monitoring visits in half.” He claims that SureSource offers “huge cost savings” over Phase Forward’s Inform and Medidata’s Rave, as well as providing “faster and cleaner” data delivery.
And that is before saying anything about the ability of SureSource to improve the sponsor-investigator relationship. Owing to the sheer diversity of systems and their associated passwords, PIs currently “spend a lot of time [merely] trying to gain access,” says Littlejohn. “Even if they’re well intentioned, they’re being asked to sign off on a database screen they don’t recognize at all because they didn’t transcribe the data and they don’t have source data in front of them.” Many busy, research-savvy PIs have admitted to Littlejohn that they routinely give their password to the study coordinator to “certify” the data is correct.
Moreover, study sponsors want sites to go through lengthy “training hoops” for their chosen EDC system with its invariably complicated and aggravating operating imperatives. Automatic query functions, for example, have shifted much of the data-cleaning workload from study monitors to site level personnel with no data entry experience as well as generated vast numbers of nonsensical, often repetitive questions.
Littlejohn says: “There’s a lot of pushback from investigators who say, ‘I can’t do this anymore’ or ‘I’ve trained on this system four times now,’ and drop out of the next trial that involves EDC. Data quality also suffers, and if that goes bad all the conclusions [sponsors] come to down the road are wrong or tainted in some way.” And that’s not even taking into account human error associated with data re-entry, first on paper during study visits and later into an online EDC system.
The first pilot testing of SureSource began at the end of March on a CRMi-sponsored ulcerative colitis trial, says Littlejohn. If all goes well, SureSource will be used on other trials beginning in June.
Littlejohn believes that SureSource may well be the “perfect solution” for academic centers, because it provides a bridge between EDC and electronic health record systems years before integration of the two technologies can be accomplished. But most trials take place outside academia and are global in scope, making mobile data-collection technology a must for simultaneous deployment.
Clinical Ink owns an exclusive, worldwide license of a patent owned by Datasci, covering the collection, validation, and transmission of clinical trial data. Datasci has granted six non-exclusive licenses in the EDC marketplace via a series of lengthy legal disputes.