The modern clinical trial is built around a 2,000-year tool invented by the Chinese. Paper. Case report forms. Signatures. Binders of paper. Trucks filled with paper. FDA warehouses trembling under the heft of it. Some industries might be ashamed. Not ours.

In the life sciences, every self-respecting company can talk about its holy process, its precious workflow, and that invariably turns out to require four or five million pieces of … paper.

So the November Nextrials announcement about accessing and recording live clinical trial data using Apple’s iPhone is a big deal. In an industry accustomed to baby steps, it’s a great leap forward. It won’t address the paper addiction. But the gadget will make the work of entering and reviewing data go faster; it will untether key participants in the process from laptop and desktop computers.

Extreme Usability

It would be dramatic to report that Nextrials slaved over the project for months, getting third mortgages on its senior executives’ homes, hiring villages full of programmers in Taiwan to make it happen. Maybe there was a fateful encounter in which Apple programmers taunted Nextrials with an all-night coding challenge? Perhaps there is a special layer of middleware that costs $214,000 and must be custom-configured by Accenture, IBM and Nextrials?

No, no. None of that. “It was ridiculous, really, how easy it was to do this,” says Nextrials co-founder and CEO James Rogers. “You’ve got to enable pop-ups on your iPhone. Once you do that, it works out of the box.” Oh. One logs onto one’s study the same way one would using a desktop computer. Oh.

Upon grasping that, we crossed seven or eight suddenly irrelevant questions off our list. Can you try an iPhone with other EDC providers? Maybe, says Rogers. “You do want to avoid a lot of Java,” says Rogers. “[Our EDC solution,] Prism doesn’t use a lot of Java. That’s a hurdle that we didn’t have to overcome.” Flash is also a no-go on iPhones.

On Safari

The iPhone uses a miniature version of Apple’s Safari application to cruise the web. Safari displays some websites a bit differently than Microsoft Internet Explorer. Here’s an Apple web page about designing websites for Safari. Nextrials, for the record, has shown customers actual trials on iPhones and not a pixel has been out of place.

Security is not an issue, Rogers says: “It still uses the same SSL encryption that you’d use on the PC. Ultimately, [hackers] have to get past our secure server. That’s no easier to hack on an iPhone than it is on a PC.”

Pinch Me

For Rogers, the user interface of the iPhone is the critical thing to understanding it as a tool for productivity in clinical trials.

“It’s the nice user interface around the navigation that makes it a real business tool,” he says. “With a finger you can tap on a data entry field. It’s a faster navigation than an interface you would see on another handheld.” Simple pinching (with your fingers, not a stylus) expands or contracts what you see on the iPhone’s screen.

The iPhone’s Keyless Keyboard

Once to you get to where you need to go, you can enter data. In theory, electronic case report forms (eCRF) could be optimized for the iPhone, he speculates. “If you anticipate that usage, you can structure the eCRF to be geared more to checkboxes and things you can do without having to type.”

Central to all of this is a large screen that is, by anecdotal reports, an order of magnitude more sharp than that of other mobile phones. This allows websites like ClinPage to be visible in all their glory or infamy—the iPhone is not confined to displaying some kiddie, special version of a website just for mobile phones. “It’s not the internet lite, it’s the real internet,” Rogers says. “The resolutions adjust to a really sharp image.”

Says Rogers of the iPhone: “You can navigate around Prism without typing something in. You can get where you want to go by tapping the screen.”

Rogers is realistic enough to know that vast volumes of data will not be entered into a clinical database via an iPhone. “Is it going to replace the PC in the study coordinator’s office? Absolutely not. I wouldn’t want to do a lot of data entry using the iPhone keyboard. Give me a full size keyboard if I am the study coordinator. But what it does provide is mobility. If you’re an investigator that’s on the road, you can run the enrollment report on the mobile phone.”

Help for CRAs?

The sheer tedium and drudgery of much clinical trial work, in our view, is a reason to throw boxes of iPhones into the process as one might toss fresh fish to the polar bears at the zoo. They’ll know what to do.

Says Rogers: “The clinical research associate (CRA) is one of the best fits for the iPhone. They’re the most mobile of all the players in clinical research. Will CRAs be able to talk their managers into buying iPhones? I don’t know.” Anything to make the work easier is a major productivity advance, especially at a time of high turnover in the clinical trenches. It will be interesting to see if large EDC providers take notice, porting their software to smart phones from Apple or other firms.

Rogers doesn’t say much, but he sounds intrigued by the possibility of using an iPhone to collect patient-reported outcomes (PRO), especially since the Apple devices don’t require the modems, cradles and other cumbersome peripherals of the Palm platform. For the record, Nextrials doesn’t offer anything in the electronic patient diary space. Not yet, anyway.

Editor’s note: a while back, we wrote about visualization tools from Nextrials in this story.