Major electronic diary providers all built their platforms around a Windows or Palm-based device that plugs into an electrical outlet. But that dependence on hardware is a bit cloudy going forward, simply because the PC-based phone companies are being hammered by Apple and being forced to re-evaluate business-oriented devices that may not be manufactured for the extended time periods necessary to support clinical research.

That may explain why invivodata is launching an internet browser-based version of patient diaries. Last week, the Pittsburgh firm announced a new platform to capture patient experiences via a desktop computer's web browser—with no Palm required. The strategy will be appropriate for non-interventional, Phase IV projects after regulators have approved new medicines and devices.

Diary In Your Browser

"There is still a large bolus of work that needs to be done after approval. The industry is getting more and more comfortable doing that electronically," says Doug Engfer, invivodata's cofounder, president and CEO. "We're using the same core technology and deploying it in a web-only application."

He estimates that just 15-20 percent of post-approval projects today have diaries. Such research, Engfer says, may be more comparable to a rigorous and sophisticated survey than a traditional ePRO project in Phase III.

The company plans to support web-based ePRO on all of the major web-browsing packages from Microsoft, Apple, Mozilla and Google. While invivodata is not enabling the ancient, bug-riddled version 6 of Microsoft's browser, it is supporting later versions of the dominant web-surfing package.

Tangled Webs

There are a few risks in using the internet for medical research. "You're a little bit limited by the subject's computing environment," Engfer says. "They could be distracted by the latest Twitter trending."

Unlike a handheld device, a browser can't beep and remind its user throughout the day. As a symptom arises, as a medication should be taken on schedule, a computer with an open browser may not be close at hand. So there are studies for which a browser-only approach will not be suitable.

Other Limitations

Beyond that, web browsers allow users to customize fonts, colors and other aspects of what they see. So the presentation or appearance of some scientific questionnaires will be impossible to control. For post-approval studies, that will be acceptable. For Phase II and III research supporting a market launch, that will not meet the standards of regulators or sponsors.

A prospective research subject who is trying to view an invivodata post-approval study on a 640 by 480 pixel screen would likely be blocked from participating. The goal: to ensure some minimal level of standardization and legibility.

Another issue: whether bias could be introduced with the internet-only technique. Differences between computer usage or internet access among subpopulations of patients could skew some results, Engfer speculates, in ways that will need to be studied.

Some Upside

Still, the internet-only approach also confers advantages. Most ePRO studies today are small. That's because of expensive hardware that must be shipped internationally, supported for technically challenged patients, and fitted with James Bond-worthy diagnostic or telecommunications accessories. A browser-based approach could obviate all of that, allowing registries and other post-marketing ePRO projects to be both massive and global for the first time.

Indeed, for projects requiring only weekly or even more sporadic input from patients, sponsors could get quick, reliable answers. Some of those projects may have patients more or less enroll themselves. In such circumstances, Engfer says, the web-based version of his software could be similar to a favorite book on a bedside table—something consulted briefly before going to sleep at night.

Tolerability Data

It's not a tangential detail that the industry's largest contract research organization (CRO), Quintiles, has had a strategic partnership with invivodata for 18 months or so. Engfer says the two firms put the web-based ePRO offering on their list of objectives at the start.

As Quintiles tries to assume responsibility for entire research programs and long-term product development from basic discovery through clinical development, Engfer says, diary technology should be able to help it identify new indications or labeling changes that emerge over a longer time scale.

The argument seems to be that competitors to Quintiles, in some cases, could be doing ePRO expertly on a single project basis but miss subtle trends that appear only over multiple studies of the same drug or across several therapeutic areas.

In other cases, Engfer predicts, the new online modality for gathering patient experiences is likely to augment sponsor understanding of subtle aspects of a drug's tolerability.

Commercial Angle

In ordinary daily usage, he explains, nonserious but bothersome symptoms like nausea, dizziness, and muscle aches may dissuade patients from staying on therapy. (Such problems have plagued the antidepressants and statins, among other classes of medicines.) But gaining insight into those issues can take time.

"Here is an ideal way to pick up signal on issues like that that relate to tolerability and relate to whether the patient is going to keep taking the drug," Engfer says. Diaries are already being widely used to find ways to plan drug labels and differentiate new products before approval. It's natural that commercially oriented marketers in the sponsor community will use patient diary technology after new therapies reach the market as well.

Vendor Group

Earlier this month, invivodata and its major diary-making rivals established an ePRO consortium at the Critical Path Institute (CPI). (There's a news release on this page on the CPI website.) Besides invivodata, the participating suppliers include CRF Health, ERT, Icon, and PHT. The CPI has a parallel, ongoing PRO effort with sponsor participation. The two efforts will try to coordinate their activities under the same person at CPI, Jason Lundy, whom Engfer praises highly.

Engfer goes on to say that the purpose of the new consortium is not to generate grand proclamations. That, after all, is what some collaborative pharmaceutical industry task forces do on a regular basis. It seems harmless enough. d9A2t49mkex

But Engfer insists that the new ePRO consortium will conduct itself in a businesslike manner and generate tangible results. The members are all promising to supply dollars and people to deliver on concrete, shared goals.

One common thread to CPI projects will be finding ways to collectively advance the science of ePRO in ways the firms cannot easily explore on their own. One current project: making a list of the most crucial, frequently used PRO questionnaires so that the validated electronic versions of such instruments can eventually supplant the paper versions. The time needed to validate a set of highly specialized, time-honored, paper-based PRO questions for the electronic environment has been one factor inhibiting the growth of the expanding diary niche.

Taken together, the consortium and the web-based version of the invivodata technology suggest that patient diaries are continuing their evolution to be a more standard element of many research projects.

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