Patient Reported Outcomes
One "adjacent technology" that is gaining momentum is electronic patient-reported outcomes (ePRO). These systems can be used
by clinical trials patients to make comments, score themselves on symptoms, and the like. Wyeth is giving patients PDA-style
computers on which they can enter data electronically. The information is uploaded from the PDAs to the company's central
EDC system, which in this case is a Web-based program that can be accessed by any trained employee at any time.
"We can review the data within 24 hours of patient visit," says Wyeth's Clarke.
According to contract research organization Quintiles, FDA is encouraging the use of ePRO in middle- and late-stage trials
to get instant feedback from patients as they use a treatment.
Some companies are still apprehensive about giving new technology to patients. BMS is looking at ePRO but hasn't made any
overtures toward adopting it. "As a result, because many of our competitors are using those types of technologies, some of
our trials suffer because we're collecting that same information still on paper," Olsen says. "And it's a struggle, because
it makes us look different and it makes us perhaps not as desirable as a clinical trial organization."
Until the standardization of clinical trials is complete, a big challenge for most companies will be choosing how much technology
to bring to an individual project.
As companies start moving up the technology ladder, they can add and in workflow components that are consistent with what
happens in a clinical trial.
For example, an average EDC system features a menu system based on the study structure. Each visit gets a page, and there
are sub-pages within each visit for standard tasks that happen in every clinical trial. These can include source-document
verification, investigator electronic signatures, electronic query management, and so forth.
Because the majority of clinical trials are still done on paper (approximately 70 percent according to eTrials), some companies
are finding it easiest to start out with projects that mix paper and EDC.
"Companies can get a simple, bare-bones data-input system, which is basically almost anything you would see on the Web where
data is input," explains Rick Piazza, vice president of product strategy at eTrials. "If a company starts out using it as
an input system for paper, they're starting to build their expertise with the system. They're starting to get comfortable
with the system, and it's a good way to lower that learning curve."
There are also cases when it is still more efficient to do paper—for example, a postmarketing study where a company is studying
very few patients and might collect only one piece of data every month over the course of three or five years.
"It might not make sense to build an entire Web site, train a set of staff at the site for a database they'll access only
once a month for a little bit of data—because no one's really in a rush to see that data anyway," Tyson says.
But even if you start out with a simple front-end system, says Piazza, don't neglect the back end. "Every EDC system should
also have robust reporting," he says. "That's a key requirement these days that every sponsor wants. They want to be able
to produce reports of the live, real-time data, and query those reports. That's something you can't do on paper, and a lot
of systems didn't do it even five years ago."