Anyone who attends a certain number of pharmaceutical industry conferences runs the risk of slipping into autopilot mode. One may hear an unrelenting chorus of the same phrases: process change and talk to the agency early and it’s important to communicate  and involve all members of your team…. Those phrases can become a sort of Musak heard at every meeting, in every session, year after year.

Such music was not to be heard at the 2008 Society for Clinical Data Management conference.  Held in Dallas, this year’s meeting had a session on the virtues of … paper! Dead trees! This was new.

Mother Of All Heresies

The session addressed some deeply felt reservations about electronic data capture (EDC) solutions. The key question was the pace of the transition of the humble case report form (CRF) from paper to electronic. We had thought the transition was slow but inevitable. We’re no longer sure.

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Many readers will nod in agreement with Michael Goedde, director of clinical data management at Human Genome Sciences. “How much ‘e,’ how much electronic, do we need in our data management world?” Goedde asked. “How is it that data management feels more difficult than it did 10 years ago? Shouldn’t it be simpler? It does not feel simpler. It feels more complicated.” Good questions.

What’s Left Unsaid

Goedde was in confessional mode. “I am getting tired,” he said. “I am experiencing so many unmet user needs when it comes to EDC. Back in 1998, at DIA in Berlin, we knew about the benefits of EDC. Why is it, ten years later, that it is still so difficult for some companies to dive in there?”

One explanation is that the EDC vendor community has not served the industry. That theme was in the air at the SCDM meeting.

Another explanation: there are deeply ingrained organizational idiosyncracies in the sponsor community. These company-specific quirks of process and trial design have never been tackled in any industry conference and never will be.

But as a result of them, certain pervasive inefficiencies have permeated many aspects of industry-based clinical trials. Since every company collects clinical trial data differently, no one piece of software can be broadly applied at all companies. Thus paper still holds a certain charm, like a long-forgotten high school sweetheart.

A Digression

These quirks in the sponsor community have now made it virtually impossible to build an off-the-shelf EDC solution that works “out of the box,” as the saying goes, for more than one sponsor or trial. Heavy customization has been the predictable solution. It works. But that ain’t software. It’s a long-term consulting engagement.

Goedde did not linger at the podium. A pity. He turned the session over to David Mastro, VP of pharmaceutical programs at The Strata Companies. It’s a supplier of paper case report forms.

Mastro himself has been doing informal surveys at industry meetings. It’s not scientific research, but it is indicative of EDC hitting a pocket of resistance. “The exclusive use of paper CRFs is definitely declining,” Mastro says. “The exclusive use of eCRFs on an organization by organization basis is tending to level off.”

Paper Partisan

From what we could deduce, Mastro is not Amish. He didn’t advocate riding to work in a horse-drawn buggy. But he does believe that his surveys and Strata’s experience suggest a harbinger for the industry. Paper, he suggests, will remain an element in some trials, even in parallel with EDC. Says Mastro: “I still see a place for paper and eCRFs and we see that in our business going forward.”

When does paper work well? In developing countries with dodgy internet connections or computer access, Mastro says. There are setup costs for EDC that negate some of the cost savings that are promised. And there is simply not a groundswell of support for EDC at all sites, Mastro contends.

Fairly or not, EDC and other technologies are perceived as tools that add to the site workload. “Some site people say ‘I don’t want to be a surrogate data entry person,’ ” Mastro says. “That’s a perception. But it’s a reality.” Just for the record, Mastro also sees some companies adhering to paper patient diaries for the same reasons. 

The ROI Mystery

At the same session, there were vendors who spoke, and spoke well. Among the familiar arguments they made on behalf of EDC were: faster database lock at the end of a trial; the now-routine usage of EDC in small Phase I studies; the ecological merits of using less paper; and the ability of EDC to help power much faster adaptive clinical trial designs. Fair points all.

But let’s get back to the basics. The fact remains that it is not clear if EDC saves sponsors money or time. It might in some cases. Or it might just move data management costs to different places in a budget, to new suppliers outside the company.

It pains us to say this. We think technology is generally good. But clear, simple return on investment (ROI) calculations of the value of EDC are hard to find. When they are available, they may be so unique as to be nontransferrable to any other organization.

Which is odd. It’s unfortunate the industry has made significant investments in EDC without being able to construct an irrefutable, slam-dunk economic case for such a central and indispensible technology. For all its happy users, it appears, the world of EDC may have some persuading to do.