Sponsors are willing to spend to make sites’ lives easier. Tablet PCs for electronic patient-reported outcomes (ePRO) seem to be an increasingly popular means to that end.

Earlier this year, PHT announced a tablet for clinical trial sites. assisTek has had a tablet for a while.

Now Pittsburgh’s invivodata is getting into the act. The firm had offered a tablet for use at clinical sites since 2004, but decided that a larger screen was necessary. This week the company announced the biomedical equivalent of a big-screen TV. The new Site Pro device has a screen that’s vast, allowing plenty of refreshing space (something you won’t see on a Palm) and huge fonts. On the diagonal, the screen measures a foot.

Prettier Windows

Selecting a device from Motion Computing, invivodata picked a manufacturer that has specialized in making computer hardware for doctors and nurses. The Motion Computing LE1700 is pretty much the size of a standard clipboard. The Texas manufacturer says the 11.6” by 9.6” portable weighs about 3 lbs. with the standard battery, giving it 2-3 hours of untethered operation. That will be plenty for clinical trial uses, says invivodata.

In your hands, the Motion Computing LE1700 device feels lighter ... and looks prettier than most Windows XP machines. (The device is just three-quarters of an inch thick.) It’s easy to imagine carrying the LE1700 around with a stack of other papers. The screen is navigated with a stylus (not a fingertip) that cannot be lost: it’s tied to the tablet by a cord.

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Big Screen: invivodata’s LE1700

The size of the screen is not just for the wow factor. invivodata notes that the device permits (with the press of a button, not a motion-detector like an iPhone or wii) both portrait and landscape mode, facilitating a transition from a paper instrument to an electronic one. “The migration of a paper scale to a Site Pro Tablet in many cases will not require a modification to the core assessment layout, reducing or eliminating validation costs,” invivodata says.

Regulatory Burden

Ken Kolenik, invivodata product manager, coordinated the effort to develop the device. He talked to sponsors and showed them options. He says people in pharma considered one common tablet size—the global positioning system screens used in vehicles—and didn’t like it. “The seven-inch screen was seen as a compromise,” he says. “We can provide multiple data transfer options” that include ethernet, wired modems and wireless, Kolenik adds.

The company’s VP of marketing, Tom Henson, notes there was no sticker shock at the $1,000-1,200 price for the in-clinic device. That range is not all that different from the invivodata-configured Palm handhelds used by patients at home.

Migration Issue

As noted, the large size of the tablet affords a potentially painless route to validating a paper-based instrument in a clinical trial, just because something from a standard sheet of paper will not have to be squeezed or scrunched or otherwise chopped up to fit. This could allay the fears of sponsors that are worried about validating paper scientific questionaires on any electronic platform.

Henson says there could be significant savings in not having to migrate, validate or user-test a paper instrument’s transfer to the tablet PC. “In the quality of life arena, you can get pretty wordy questions, with lots of choices,” he says. In our demo, the buttons and words were easy to read.

Save A Step

Across the industry, it’s common to mix and mingle paper and electronic systems. And invivodata is happy to continue to oblige by supporting such projects. But the company points out its system for managing ePRO data, called EPX, combines data from its site device and handheld patient diaries. Used together, the two devices can eliminate a bit of data integration and reconciliation.

Someone from a sponsor or site would not need to type the contents of an in-clinic paper assessment into some other system. Notes Henson: “We can eliminate that step when they put it into an electronic system.” The Palm devices and the tablets push data into the same underlying EPX database.

invivodata recently announced that just such an approach was used by Sucampo to win FDA approval for a new gastrointestinal indication. In that research, the sponsor selected both an in-clinic device for clinical research coordinators and a device for patients to take home. There’s a news release about that on this page.

Academic Publication

Like rival PHT, invivodata is positioning itself as a thought leader in the ePRO arena, principally on the basis of this oft-cited article in the British Medical Journal showing how inaccurate paper patient diaries are. In a continuation of that theme, the company alerted us to a new article by Chad Gwaltney at Brown University. (One author on the paper is Saul Shiffman, an invivodata co-founder.)

Recently published in Value In Health, an International Society for Pharmacoeconomics and Outcomes Research (ISPOR) journal, the article examined 46 different studies with 278 scales.

Conclusion: paper and electronic modalities (from a scientific and psychometric perspective) work equally well. “We have demonstrated that written assessments administered on paper and by computer are equivalent,” the article states. “This suggests that scores obtained via the two modalities are directly comparable.”

 

 

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