By Ann Neuer
January 19, 2010 | With the market for electronic patient report outcomes (ePRO) heating up, ePRO provider PHT Corporation is launching a significantly updated version of StudyWorks, its online portal. Sheila Rocchio, vice president of marketing, says that the portal’s expanded capabilities are designed to accommodate the sector’s growth, fueled by the December release of a final PRO guidance by the Food and Drug Administration (FDA). Several sections of the guidance are devoted to ePRO.
“We know that 25 percent of studies are now including PRO, and we believe that of those studies, approximately 25 percent are adopting ePRO. This is a global figure, and we are expecting that number to rise, especially with the final guidance now in place,” Rocchio says.
To handle the anticipated upswing in the sector, the StudyWorks portal has come to market with several new features. The most significant is the inventory reports meant to reduce the challenge of tracking ePRO devices such as SitePad, which resides at the investigative site; and LogPad, which is distributed to study volunteers.
“This is the biggest change StudyWorks offers. The reports allow study coordinators, monitors, project mangers and administrators to get an up-to-date view of where the hardware is for any study. A major issue that people perceive with ePRO is that is it logistically difficult to manage and track all of the devices on a global basis, and pharma does not want to be in the hardware business. There is a movement away from ownership and toward a management model,” says Anne Pelz, manager of product management.
Pelz explains that as trials become increasingly global, stakeholders have had to make sure that devices arrive on time at the proper locations. The revised StudyWorks relieves the site and sponsor of that burden by including tracking numbers for shipping, the number of devices at each site, and those that are still in inventory. As soon as a subject is enrolled, the system assigns a device to the individual and computes how many are left. If the site enrolls more subjects than expected, it can request more hardware through the Study Support Center, and all of this information is tracked in StudyWorks.
The ability to create real-time inventory reports is the result of PHT’s recent implementation of the Oracle e-Business system. Rocchio explains, “We know when devices are shipped and received. All of the ordering is done in the Oracle system.” Prior to this implementation and integration with StudyWorks, customers received weekly updates on the details of the usage patterns of their devices. Now, sponsors can simply pull up this information.
In addition to the inventory reports, the upgraded portal boasts a number of other elements. First, sites and sponsors can see ePRO data from SitePad and LogPad more quickly as StudyWorks offers transparency through real-time, 24/7 access to data collected from both devices. Next, there are improvements to e-mail alerts, which serve several purposes. They are used to advise the study personnel as to patient compliance issues or if a patient reported outcome signals intervention. Improvements come in the form of fewer clicks needed for the site to access the data that generated the e-mail alert. For example, in an asthma study, if a score worsens over a period of time, the site is notified and getting to that information is easier for the study personnel. And with this information, the site can alert the patient.
Sites are also notified by e-mail alert if they have failed to enter information, yet the subject continues to make entries. “This can be caught in a number of ways—in screening or in treatment,” Pelz comments.
Currently, approximately 45 studies are using the upgraded StudyWorks portal, and benefiting from the new features. More will come on board as customers deploy new studies.
Rocchio says that the new features are in response to customer feedback, and reflect PHT’s strategy of listening to its customers to consistently improve services that help them better manage their clinical trials.