By Ann Neuer

April 7, 2008 | PHT Corp. is expanding its suite of electronic patient reported outcomes (ePRO) devices with the recent launch of the SitePad Tablet. This large screen mobile device uses the Samsung Q1 Ultra Mobile PC and actually resides at the investigative site. It is not sent home with the subjects participating in clinical studies.

This is an important point of differentiation according to Phil Lee, president and CEO of PHT. Lee says that the industry still overwhelmingly uses paper to collect patient reported outcomes, typically citing the cost of providing each subject with his or her own ePRO device as a reason for sticking with paper. This is particularly true for registry and Phase IV studies where each site could have 30 to 40 enrolled subjects, making it cost-prohibitive to provide all subjects with devices. Lee says, “SitePad is a very cost-effective solution, as one SitePad can support many patients.”

At a time when the FDA is emphasizing greater patient input in clinical research, sites are scrambling to find alternatives to the paper questionnaires used to collect patient reported outcomes. Studies that often have a site-based questionnaire component include oncology, pain, CNS, Alzheimer’s disease, and psychiatric trials, as well as registry studies and Phase IV programs. These site-based questionnaires typically leave the sites awash in stacks of paper that have to be reviewed for accuracy, sorted and assigned to the appropriate patient and site visit.

Phil Lee

The SitePad Tablet eliminates those inefficiencies by offering an easy-to-use device with a large seven-inch diagonal touchscreen. “The screen is about half the size of a piece of paper, so it is easy to see and large enough to accommodate complex questionnaires. We’ve designed the product so that if you can use paper, you can use this product,” Lee says. Subjects who are using the SitePad Tablet for the first time can practice on a sample questionnaire, which includes multiple-choice questions and questions with visual analogue scales.

Data collected by the SitePad Tablet are transmitted to a hosted central server in real time using an integrated Ethernet port, without relying on wireless networks. The data on each patient then become available to the site through a Web portal.

Importantly, data collected on SitePad can be integrated with other electronic systems at the site, such as electronic data capture (EDC), clinical trial management systems (CTMS) and clinical data management systems (CDMS). This is possible because the product conforms to CDISC standards and can export data in either CDISC XML or ASCII formats for interchange among the systems. According to Sheila Rocchio, VP marketing, not all studies require data integration, however, and in those cases, the data transfer is done primarily using SAS technology. “We are seeing more of a move toward integration, but still, a significant portion of the studies don’t require it, and in those instances we provide clients with a final SAS data set containing the PRO data,” Rocchio explains.

SitePad Tablet is meant to complement, not replace, PHT’s popular LogPad System, which study subjects take home with them. The company is aiming to start its first SitePad study in the June to August timeframe.

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