At its annual customer conference last week in its home town of Boston, PHT reviewed the last few years of growth in the electronic patient-reported outcome (ePRO) niche. Business has been good. The company says it is annually shipping 40,000-50,000 devices all over the world.

Perhaps a third of all clinical trials, the company says, have a paper or electronic diary component. Now that electronic case report forms are standard, many sponsors are turning toward adopting electronic diaries. Recording subjective patient experiences on paper while gathering reams of other data electronically remains a common approach. But even slow-to-change sponsor firms are glimpsing the inherent absurdity and regulatory peril in such practices.

But PHT also had a bit of actual news. The firm is working on adapting its ePRO software to run on devices other than the existing Palm and Microsoft mobile platforms, both of which are being warehoused by large, indifferent corporate owners which supply minimal marketing support for their also-ran offerings.

New Tools

Instead, PHT said, it will able to run patient-reported outcome projects on the market-leading Android and Apple smart phones and tablets.

"This technology will actually run on the patient's own phone. We're trying to address the changing landscape and the internet," said PHT president and CEO Phil Lee. "What's been stagnant is the [computer] desktop. What's grown have been mobile devices and tablets," he continued.

While smaller ediary firms have selectively supported Apple devices for clinical research in the past, PHT could be the first major ediary firm to support Android. That could be a plus in global research projects. In remote regions of the planet, Lee assured the audience, the devices would collect data while offline, then upload it when a network connect became available. "We predict this will be a key to mainstreaming ePRO adoption," Lee said.

In some cases, Lee said, the software for a trial might be accessible via a web browser on a phone or tablet. In other cases, it would be a separate, dedicated app that users would download like any time-wasting game or noise-making novelty.

Murky Timeline

After the meeting, PHT was careful to explain to a reporter that its new system was still under development. PHT gave no date when Apple or Google devices might be collecting patient data for a live trial.

As with its existing deployments of ediaries, PHT intimated that its foremost concern will continue to be the integrity of the science. Thus it will never permit variable user interfaces or divergent screen proportions or other ephemeral issues with new hardware to interfere with what a sponsor needs to study.

So, as a hypothetical matter, if a particular electronic questionnaire for, say, asthma patients would be unlikely to display exactly as needed on certain Android devices, PHT might not allow any Android users to download that asthma app or view that asthma web page. Rather, PHT said, it would disseminate the apps exclusively to users who had the type of device that would handle the ePRO instrument in a manner that corresponded exactly to what sponsors and regulators specify.

An agnostic, any-screen approach to diary hardware would necessarily need to preserve most of the functionality of PHT's existing platform. The company is quick to say that it expects not an iota of diminished control of the look and feel of any trial running on Google's operating system or Apple's hardware. In brief, it expects to be able to guarantee that an instrument for, say, irritable bowel syndrome runs as flawlessly on an iPhone as it does on a Palm device that PHT has used in hundreds of trials.

The iDiary?

Should the details be worked out, the consequences could be refreshing. If some fraction of patients could use their own phones, they might need less training. The budget of the trial would be considerably lower, even if sponsors purchased phones or tablets for some subset of patients. Fewer logistical headaches related to tracking, shipping and repairing so many devices, cradles and electronic tchotchkes will be another factor. On the down side, for the 15 percent of ePRO projects that connect with small medical devices to record respiratory function, sleep patterns or blood sugar, there would appear to be a delay before Google and Apple would support such peripheral tools.

Over time, there might be even more far-reaching effects. Could the delightful Apple interface make science, God forbid, fun? Other patients might be drawn to participate in research by the prospect of receiving the device at the end of the study.

Long-term compliance with a post-approval study might be higher if the patient was using a smart phone that was well integrated with his or her life, within the ordinary daily events of a job or bringing children to soccer practice. Today, of course, patients must drag around a pharmaceutical-related ediary in addition to communication tools for personal use.

Interface Pitfalls

The PHT technology, tentatively code-named "Leapfrog," does pose risks. The Google phone platform is laissez faire, notoriously unregulated, with many apps not running on certain phones and many phones displaying the same app in different ways. There are probably thousands of permutations of physical devices and various versions of the Android operating system, complicating the testing process for a scrupulous sponsor firm.

The Apple mobile platform also has a mix of various operating systems and phones which do not support all apps. But both of those are a far cry from the Palm world where most top ediary companies have the deepest expertise.d9A2t49mkex

Google views its hands-off approach as more liberating and populist than Apple's tightly controlled, even snobby gate keeping, under which some apps are rejected or left unapproved in a nebulous limbo. Google, in contrast, is more tolerant of the quirks and eccentricities of the application development community, and less inclined to enforce exacting rules about how Android programs must look, feel or run.

The bottom line for drug companies and PHT? Whatever their stated intentions, it could be difficult to have complete certainty about the performance of trials on Android devices. After all, many of the very manufacturers of Android devices have limited knowledge of which apps do or do not run on their own rosters of phones.

Good Timing

In the end, the move holds out the possibility of resolving a chronic issue in ePRO research. The industry's multi-year timelines for its complex projects are completely out of sync with a consumer electronics marketplace in which choices change every few months.

Assuming that no new entrant displaces Apple or Google in the smart phone category, the industry could acquire a bit of latitude for longer term planning. The Palm and Windows mobile brands have fairly murky prospects at the moment; their destinies are being charted inside lumbering IT corporations that are slowly and bureaucratically trying to figure out a response to the potent, apparently unstoppable Apple and Google juggernauts. Relying on iPhones and Android devices sidesteps the possible demise of either the Palm or Windows mobile franchise, no matter what glorious history those brands may have.

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