It’s easy to get bedazzled by smartphones that can deliver patient-reported outcomes (PRO). But that may not be the most common way that the industry is trying to record such data.

The Pittsburgh e-diary company, invivodata, has examined some 5,000 clinical trials from the 2007 time frame in clinicaltrials.gov.

Using that data, its own projects, and those of competitors, invivodata predicts that roughly 6 percent of all trials have an electronic patient reported-outcome (ePRO) component. Perhaps a fifth of paper diaries have migrated to handheld electronic formats, the company estimates.

Tools For Sites

But there could be even greater growth ahead. Another segment has not yet been fully quantified: the tablet computer. Invivodata and its competitors have launched new or enhanced tablets in 2008. Indeed, clinical trial devices for patients to take home may not be the biggest niche at all. “This site-based market is potentially much bigger than the diary market,” says Tom Henson, invivodata’s VP of marketing. “It’s at least double.”

Beyond that, invivodata estimates it has now won about a third of the market, with another third claimed by PHT of Boston. The remainder, presumably, is managed by companies like CRF, Arrowhead Electronic Healthcare, assisTek, etrials and Symfo.

Revalidation Fear

Henson says there may be a bit of ongoing confusion in the industry over exactly how daunting or obligatory it can be to revalidate a paper-based PRO instrument. “We’re finding a lot of misunderstanding around validation,” he says. It’s not that re-validation won’t be necessary in some circumstances. But some therapeutic or epidemiological experts may not fully understand the real regulatory obligations. Says Henson: “It depends on the specific trial and premises.”

In a chat at this summer’s Drug Information Association meeting, invivodata’s chief operating officer, Bob Young, reminded us that his firm’s devices had captured the data for the largest controlled allergy vaccine trial, run by Allergy Therapeutics. That Phase III study included 1,000 patients at 90 sites in the U.S., Canada and Europe.

Calling In

“We are very pleased with the results of this landmark trial and the manner in which invivodata captured this critical data,” Allergy Therapeutics’ Jutta Amersdorffer said in a press release. She’s head of clinical operations and pharmacovigilance. “Their understanding of the complexities of international clinical trials and their flexibility in meeting our changing trial needs, including the addition of significantly more sites and patients during the recruitment phase, was critical to its success.”

Young says that basic blocking and tackling is taking on higher prominence in the ePRO industry. Something as mundane as a multilingual help desk can be a plus. “How many calls can you take?” he said. “The help desk needs to be scaled in terms of volume and language support.” His company’s help desk offers support in twenty languages and can tackle additional languages as needed.

Project Management

As the industry becomes more international, there are emerging cultural nuances to ediary projects. Clinical staff from Eastern Europe or Asia may attend a training session, listen carefully, nod wisely. But Young suggests that their comprehension of the technology may not be as deep as sponsors would like. “Unless there is someone who can talk them through it in their own language, they’re not as successful,” Young says.

He reports that invivodata has been hiring—trying to pick the best people it can find to differentiate itself. Ninety days of training is standard. “Service is where the rubber meets the road,” he says. The goal is to have clients mention a particular invivodata project manager and express the desire to work with that person again. Says Young: “What you want to do there is put the right people in front of the customer. People like to work with people they like. ‘I worked with Sally. I want to work with Sally again.’ That’s music to my ears.”