It’s not exactly a news flash that there are major problems with paper patient diaries in clinical trials. Let’s just take two massively important problems: Patients don’t fill out paper diaries when they say they do. And there’s no need to puzzle out something scrawled in another language, because the electronic systems can automatically present the answers in whatever language you prefer.

And yet paper diaries remain popular in clinical trials. To assess why, the organizers of the recent Drug Information Association (DIA) conference presented a debate with a ponderous title. “The Pros and Cons of ePROs: Resolved that Electronic Technology Should Be Used To Capture Patient-Reported Outcome (PRO) Data In All Clinical Trials In Which PROs Are Captured.”

There were a few comments from Laurie Burke, director of the study endpoints and labeling developing team in the Office of New Drugs at FDA. Unofficially, she’s the czar of e-diaries. Speaking at four other sessions in Atlanta, Burke was taking a well-deserved breather at this particular session.

No Contest

Greg Gogates took the pro-ePRO side of the debate. His presentation was all the more powerful for being understated. VP of quality management at regulatory affairs at CRF, Gogates was in a relaxed and playful mood, apparently as bemused as if he had been asked to debate whether water is in fact ... wet.

“Electronic reported outcomes add functionality that is not available with paper,” Gogates said, listing some of the advantages of electronic techniques. He cited conditional navigation through questions, audible alarms, real-time edit checks, automatic help prompts, and guaranteed collection of a patient’s experiences at a time that must be contemporaneous with the intervention.

Where’s The Controversy?

Plus, he said, electronic PRO trials can monitor patients remotely. “This is a big feature that everybody likes,” Gogates says. “You can check patients and find out where they are with the treatment.”

Five years ago, Gogates said, ePRO was a tough sell. That’s no longer the case. “You can believe 100 percent of the data you collect,” he says, noting that one vendor in the industry (his own firm, perhaps?) has completed 500 studies with 400,000 patients at 20,000 investigative sites for 50 different indications.

Demographic Issue

In response to a question from the audience about whether the devices can be skillfully used by the elderly, Gogates conceded that moderately senile patients might not be capable of using either paper or electronic diaries. But generally, he said, elderly patients brag about their flashy electronic gadgets to grandchildren. “They say, ‘look, I have a toy too, and no, you can’t touch it,’” Gogates says. “I would disagree with the idea that older people don’t like the devices.” 

As for the pro-paper side of the debate, Daniel Mullins of the University of Maryland stepped to the podium. An economist, he had graciously agreed to speak at the last minute on behalf of another speaker who had to cancel.

The Opposition

There is no doubt that Mullins was a delightful and perceptive speaker. Because of technological problems with the laptop in the session, the proceedings had been delayed. “Had this been a paper based session, we would have started on time,” he joked.

But from there on, Mullins’ presentation was disappointing. He asserted hat the devices might be more easily or confidently used by selected categories of patients; and thus there might be scientific bias along gender, age, or socioeconomic lines. It’s an interesting idea. But he offered no evidence to support it.

Lopsided Discussion

“What do we lose in a virtual world?” Mullins asked rhetorically. “There is something about a virtual world that makes us uncomfortable. Intuitively, we are a little worried about a virtual world.” Huh?

We don’t mean to pick on Mullins. But the DIA debate left us wondering where the defenders of paper diaries are really hiding—and why the adoption of ePRO has not been more robust. Is it the cost of the devices? Global support of them? Connectivity and telephony issues? Concerns about drift and disarray at Palm, a key manufacturer of some devices in clinical trials? The shortage of validated scientific instruments that have been adapted for the electronic realm?

The fascinating thing is that with so many advantages to ePRO, and so many profound scientific issues with paper, any trials are unfolding on paper in the year 2007. Readers with ideas about why paper patient diaries remain so popular are welcome to contact .(JavaScript must be enabled to view this email address).