The Seven Deadly Sins of EDC

June 1, 2010

Applied Clinical Trials

One of the first sessions to get underway this conference will be Ross Rothmeier's, Senior Director, Global EDC Solutions, for Covance. The Monday June 14th 10:30 am session will essentially be a culmination of all the lessons Rothmeier has learned over his 17-year career blending clinical trials with electronic data capture technology.

Aptly titled "Chaos and EDC: What to Avoid if You Possibly Can," the Princeton-based expert will reveal what he considers to be the seven deadly sins of EDC. Through a consolidation of war stories, both personal and those shared with him by other seasoned EDC veterans, Rothmeier hopes to provide attendees with the kind of insight that usually only comes by way of mistake. "Hopefully,” he explained, “they'll walk away with an a-ha that says 'Wow, I really wonder if this is a good idea for me to be doing.'"

Like falling for what's cool. It doesn't only happen to eighth grade girls. It happens in EDC and it's the first deadly sin, according to Rothmeier, who fell victim to the "cool tool" a short while after starting his career. "

Back in 1993 we had this great vision that handwriting recognition was going to be the wave of the future," he said, "and we could let physicians use tablets and handwrite their responses to questions on CRFs, and then we would just use that as the data."

Unfortunately for Rothmeier and his colleagues at Park-Davis Warner-Lambert, that vision went from great to blinding when real-life set in. So smitten were they with what was cool, they overlooked two everyday obstacles: Doctors' illegible handwriting skills and the technologies' immaturity—tablets took up to three minutes to load a new page and could weigh an uncomfortable 15 pounds. "The idea died a slow and painful death to the point where we were doing the data entry anyway," said Rothmeier.

Expect similar hard-learned lessons to accompany the rest of the deadly sins Rothmeier plans on covering, including numbers two and three, "Building Your Own EDC Tool" (don't even think about it!) and "Piloting Until You Drop," an incremental dip-your-toe-in-the-water approach to EDC that can drag on for years. "Pilots don't save money on EDC," warns Rothmeier, "there's absolutely no evidence to suggest that, that I'm aware of. In fact, what it does is it slows you down from actually moving forward."

For Rothmeier, moving forward is as necessary a component of a successful EDC plan as is aligning process objectives with organizational goals. Which means first coming up with an answer to the million-dollar question, "What are your goals?" That was a huge lesson Rothmeier said he learned along the way that many in pharma he's crossed business paths with never considered. They wanted EDC because "It's what everybody's doing" or "It's the wave of the future," reasons as amiss as EDC Deadly Sin #1: Wanting it because it's cool.

Failing to identify specific goals for EDC, such as to reduce monitoring costs, is not using it properly. Rothmeier describes it as an "enabling tool," which means sponsors must know how they want to use it. "The misstep," he says "is that they expect EDC in and of itself to just somehow magically make money." Perhaps the 8th deadly sin?

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