Insights And A Peek Into The Future For PRO & ePRO

By Sara Gambrill

PHT Corporation's U.S. PRO & ePRO Congress, held in Boston Nov. 9-10, shared electronic patient reported outcome (ePRO) adoption growth numbers, discussions of new regulatory guidance, actionable information that can ease site and study subject burden from ePRO, PRO and ePRO in post-approval, and lingering reasons for sponsor reluctance to adopt ePRO. In addition, PHT unveiled a project it's working on that could have broad implications for ePRO adoption.

ePRO Adoption Grows
Phil Lee, president and CEO of PHT, kicked off the meeting by demonstrating the growth of ePRO adoption during the past decade. Lee defined PRO and ePRO adoption as clinical trials that collect PRO and ePRO data as primary or key secondary endpoints. In 2002, when there were roughly 4,000 clinical trials being conducted, only about 30 of them used ePRO. This year, Lee estimated that about 5,000 clinical trials were conducted, and of the roughly 1,500 using PRO, about 30% to 35% of them were using ePRO. According to Lee, ePRO adoption skyrocketed from 30 clinical trials in 2002 to a 17-fold increase of 525 in 2011. He broke these 525 down further by estimating that 250 of them used handhelds, 80 used tablets, 30 used interactive voice response (IVR), 35 used the Web, and the remaining 30 used digital pen, SMS, or cell phone.

A New Generation Of ePRO Clients
At the end of his talk, he unveiled Project Leapfrog, which PHT undertook "to address the changing landscape of devices." In 2002, most people accessed the Internet from their desktop, but, today, many access it from mobile devices and tablets, Lee said. PHT is working on what Lee calls "the nextgeneration ePRO client, who wants to work on a wide range of devices." The company is developing the technology to be flexible and run like a modern-day app. The key, according to Lee, is that this technology will run on the patient's own phone, thereby reducing the cost burden of shipping devices and training patients on devices. Leapfrog will integrate fully with PHT's end-to-end solution. He followed his description with a live demo, but there is no delivery date as of yet.