Taking Clinical Computing in Hand

I finally joined the teeming hordes and broke down and purchased an iPad 2 recently. After the pre-requisite interminable waiting period it arrived as cute and friendly as everyone says. Among other things, it brings new productivity and flexibility to the time-honored tradition of bathroom reading. While it hasn't caused me to throw out my laptop just yet, it's easy enough to understand the appeal. But I haven't seen the iPad make much of an impact yet in clinical research.

It's certainly fun to show off to your neighbors. The elegance of the device simply cries out for attention-most people at first glance want to touch it, much like an infant reaching out for a glossy picturebook dangled before her. And the touchscreen interface is so much more natural than the mouse and keyboard. A browser on a tablet can literally put information at your fingertips-as you touch each link to make it spring to life. A tablet, like a phone, has features that scream of mobility-such as the ability to use GPS location-based applications, flash and video photography, in addition to web browsing and e-mail.

Smartphones and tablets are also becoming increasingly more intelligent and powerful with each passing month. It's possible that mobile devices will soon supplant the need for a separate full-featured laptop or desktop computer for many people (just as the cell phone is replacing the land line in many homes). One iPhone/iPad app (Email 'n Walk) seems to have been designed for those who live on their phone-it uses the camera feature to show you the obstacle ahead that you're about to run into while you're preoccupied e-mailing or texting. This allows such mobile addicts to experience the external world entirely through the lens of their iPhone without ever really having to look up into the face of reality, which is, no doubt, an irresistible appeal for some.

This new generation of tablet computers led by the iPad has captivated the market precisely because such devices were conceived as grown-up cell phones, and are thus in many ways more intuitive and familiar than computers, even Macs. These are not the clunky Windows tablets of prior years (which were really laptops with a touch sensitive screen)-these are liquid information.

Mobile devices have the ability to run applications in their native operating system or within a browser that connects to a server much like any other PC. Of course, the phone/tablet will have tradeoffs in terms of operating system features, screen real estate, and keyboard inputs, so not all browser apps can be effectively used on a mobile device. Yet theoretically, support can be extended to many applications that currently are designed to run on personal computers-even though many of these currently work only on Internet Explorer (Windows Phone, anyone?), not mobile browsers like Safari and Chrome.

Clinical trials and medical apps

Getting back to our industry, a quick glance at the iTunes App Store already finds a small handful of clinical trials apps ranging from simple reference guides (a glossary of terms, a nice app about the NCI CTC Toxicity grading scale) to apps that help find clinical trials for potential research subjects. Broadening the search to "medical" uncovers thousands of more apps for all types of healthcare professionals, patients, and the general public. These include additional reference and educational apps, but also functional electronic medical record system apps, medical image viewing apps, and, in the case of a tablet, a handy form factor for reading medical journals. A quick look indicates more than 1,500 medical apps also available for Android, which is rapidly chasing Apple. While most of these have little direct relevance to clinical research, it's clear there's a lot of action in the mobile apps space in health-related areas, as well as everywhere else.

One useful design rule for effective mobile computing is to utilize the native productivity apps that are supplied with the phone wherever possible instead of inventing redundant functionality within an app. For example, phones are very good reminder systems-alarms, events, and notifications (which can be about taking medication or collecting data just as easily as they can be about reminding a teenager to come home by 10 p.m.). For some people, they replace wristwatches, notepads, mp3 players, game consoles, and a number of other everyday objects. A person lives with their phone. Phones and tablets tend to have some familiar features (e-mail clients, calendars, contacts, notes) that can be integrated with larger services but present a singular, familiar user experience in the palm of one's hand that are best reused in their native form even within other special purpose apps.

What's next?

So what types of applications make most sense for the new tablet in our industry? Obviously the iPad appeals to both patients and physicians for show and tell demonstrations. There's something particularly arresting about multimedia on a tablet that never quite seems the same on a laptop. In fact, some of the best opportunities are likely to lie with those apps that speak directly to the patient-either providing information or capturing it, although mobility doesn't always matter in such cases.

On the other hand, tablets do not seem particularly handy for typing, so I wouldn't recommend writing a study report on one.

Nor does it seem to make sense to run a complex EDC system on a tablet yet-especially if you have to type in lots of text entries. Then again, for some types of trial data capture such as ePRO, registries, and even some large scale trials with a relatively small and constrained set of data points-it may be just what the doctor ordered. I imagine many physicians would much rather sport a sleek tablet instead of a chunky laptop during patient encounters.

ePRO is an obvious place to start, since patients are probably more likely to provide timely data on a device such as a smartphone that they'd normally carry with them anyway. Yet the mainstream vendors still seem to be working on aging platforms such as PalmOS or Windows Mobile/PocketPC-not exactly the hotbed of mobile innovation these days. The traditional excuse for being several hardware generations behind in the ePRO world was to blame regulatory requirements and validation-multi-purpose devices (especially those that may be-shudder-fun) were the devil's gateway to untrustworthy data. Yet in the corporate world even the rules of Dilbert's Mordac the Preventer of Information Services are bending-and the iPhone and iPad have had a lot to do with that. Trial subjects, as well as doctors, coordinators, and clinical research associates (CRAs) may already be using an iPhone-and why shouldn't they be able to use it for research activities-even regulated ones? Of course each supported device requires qualification, precautions and procedures, and a risk-based analysis that verifies conformance of the application with ALCOA principles (ensuring that the data are attributable, legible, contemporaneous, original, and accurate). But this is hardly insurmountable; after all, if we can do our banking and trading on a mobile device, we must have some confidence in the security of data. Besides, having such patient-reported data apps run on the web with support for mobile browsers on multiple devices makes much more sense in today's world than a dedicated special piece of single-purpose hardware.

Perhaps one of the most logical initial target customers is our original road warrior, the CRA. Monitors already spend far too much time on the road, and many would probably leap at the chance to learn about their studies while on planes and fill out and submit monitoring reports right at the site using mobile devices. At the simplest level this may involve taking advantage of contacts and calendaring to help manage basic communications and visits with sites.

An interesting longer-term opportunity involves the potential to better employ complex event processing from servers. Databases are very good at keeping track of information, and a rules engine can be set up to identify new events or actions that may be required at specific thresholds. Because phones are very good at notifications, alerts can be sent out to a mobile workforce in the event of a serious adverse event, for example, or an upcoming project deadline (like any other calendar event).

While it might not yet make much sense to port a full EDC system to a phone (though arguably a tablet is a different story) it would seem to be entirely logical to have some capabilities such as the ability to look up queries outstanding or access site performance or quality metrics; perhaps even logging of source document verification for easy access by CRAs on the road.

So perhaps it's up to the CROs to equip their CRAs for this technology-enabled new journey (if they haven't begun to do so already). I'm sure there are plenty of CRAs willing to trade-in their 10-pound laptop for an iPad, which doesn't sound like a bad recruiting technique either.

Wayne R. Kubick is Senior Director, Life Sciences Product Strategy at Oracle Health Sciences. He can be reached at wayne.kubick@oracle.com.