Paying lip service to the woes of the investigative site is a time-honored hobby in the world of clinical trials. Doing something to really help the site? Rare.

Boston patient diary company PHT is trying to change that. It has revamped its electronic patient-reported outcome (ePRO) software to run on the Samsung Q1U-ELXP Ultra Mobile PC.

The Samsung tablet has been on the market a while. Presumably any bugs have been worked out. The device is much bigger than a mobile phone, with a full thumb-worthy QWERTY keyboard and a screen measuring seven inches on the diagonal. The tablet is approximately the size of a piece of paper folded in half or, for the geeks, its width-depth-height measurements are 8.96 x 0.93 x 4.88 inches.

Big Screen

So the Samsung machine is much smaller than the earliest tablets, which were roughly the size of a full sheet of paper. PHT chose the Samsung because it was sufficiently cheap ($800 on Amazon) and light (1.5 lbs.) to be easily carried by investigators and clinical research associates and coordinators.

Perhaps half of all clinical trials have an instrument to capture quality of life data, estimates PHT president and CEO Phil Lee. Questionnaires on paper are the norm. “For a long time, clients have been asking us to develop a device to capture that information right at the site,” he says. One PHT customer expressed an interest in having one of the Samsung devices for every trial.

New Operating System

PHT had to port its software away from the ancient and wobbly Palm operating system. Instead, the PHT programs will now run on Windows XP, at least when the Samsung device is concerned. The investment that went into the Palm-Windows transition will be easy to apply to other types of PC hardware in the future.

Like Apple’s iPhone, the Samsung unit responds to the touch of a finger. Which is why PHT decided to spend considerable time fussing over the user interface, ensuring that the typography and design of its screen would be easy to read. (We were not shocked to hear that some built-in aspects of the grim Windows user interface did not get used, simply to make the PHT screens as easy to navigate as possible.)

Finger Pointing

“The ability to use a finger, not a stylus, to push the choices will add a level of ease of use that will be unsurpassed in this particular space,” says Lee. Patients will need no training to use the Samsung device, he says. Health care professionals should be able to tap out the necessary forms faster on the device than on paper.

A device for patients and clinicians alike is not a new idea. But the company is acknowledging that some patients may find it easier to use the larger tablet screen than those on smart-phone-size devices. Some in the industry, apparently, have worried about how legible the small screens really are.

At The FDA

From a regulatory perspective, PHT anticipates no major hurdles. Partly that is because it has been working in the patient-reported outcome niche for so long. But there’s another reason. The larger screen will allow some study questions that were previously divided in half on Palm handheld diaries to be displayed in their entirety on a single screen using Samsung devices. That should help at the FDA.

“I see no new regulatory issues. You will never have to compromise the wording of the question. Everything is there,” says Lee. “All the relevant information is presented at the same time.” That should even be true in more verbose languages like German, he predicts.

The Samsung Q1U-ELXP Ultra Mobile PC from PHT

‘Is That An L or a 1?’

Needless to say, the patients’ and medical professionals’ answers will be transferred into the PHT system with none of the Dickensian complexities around handwriting transcription or interpretation. (Out of range data is impossible using electronic PRO tools.) Such issues are still an element in paper-based trials, even in 2008. As such, the PHT tablet is an “e-source” solution, with no paper source documents. PHT is not shy about that; nor is the company promoting it. Your correspondent can only guess there may be a concern about a lingering emotional affection for paper among some sponsors of clinical trials. 

In light of the firewall and networking problems that arise with wireless solutions in many hospitals, the PHT tablet uses a different approach. It connects to a PC using an ethernet cable.

Simpler Work flows

PHT’s VP of marketing, Sheila Rocchio, suggests that just managing the schedules of complex series of questionnaires in some studies is a significant burden that the new product may alleviate.

She says that it can be onerous to keep track of which patient visit requires the use of which questionnaire. Because the new device connects to the rest of the PHT trial-management system, known as StudyWorks, it can take care of worrying that Patient #41A083 needs to fill out a particular questionnaire this week, and a different questionnaire next week. “You can make sure they finish each questionnaire before they move on to the others,” she notes.

New Uses?

Rocchio also proposes that the FDA’s new interest in monitoring suicidality across a variety of therapeutic areas, mentioned in this ClinPage news brief, could be a challenge easily handled by the tablet. Rocchio says that “For that questionnaire and other questionnaires that have complicated scoring algorithms, it could make it easier for clinicians to ask the question and do the scoring associated with it.”

PHT says its team has been trained on the new Samsung tablet, and that new trials could go live with it as soon as June, 2008. The Samsung tablet will be presented at trade shows over the next few months. There’s more information about the device here, on PHT’s website. This story is a recent interview with the company.