It's Standards Time - Pharmaceutical Executive

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It's Standards Time
Pharma does EDC in clinical trials, but is anyone doing it right?


Pharmaceutical Executive


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."

Stepping Up

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."


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