Should the life sciences be in a self-congratulatory mood about moving away from paper and toward electronic data capture (EDC)? Nope.

For Ron Waife, president of Waife & Associates, it may be premature to ask John Williams to compose a symphony to celebrate the shift. Waife is simply not sure EDC’s full potential is being, well, captured.

He spoke to that question at the recent Bio-IT World Expo. Waife’s presentation was the most thoughtful and provocative this correspondent has heard in 2008. (Which was all the more surprising at a conference focused on IT and drug discovery.)

Defining Eclinical

Waife offers a more rigorous and credible usage of the term eclinical than we usually hear. These days eclinical can mean anything, from “electronic” to “electronic data capture” to “a homegrown system in which we linked two other systems.” Just as all the children in Lake Woebegone are above average, all sponsors are ahead of their peers in eclinical.

Don’t get us wrong. ClinPage is as smitten by the jazzy e- and i- prefixes as anyone, and to prove it we’ll get to Waife’s i-definition of eclinical in an e-minute, just as soon as our glorious Windows laptop restarts itself for the fourth time since breakfast.

Tech Mismatch

Waife, to begin on an upbeat note, recognizes it has taken twenty years of gestation to get the industry to its present level of EDC usage. Even so, he says, “We have the status quo. We’ve been shoehorning computer technology into a paper–based organization which uses a paper–based work flow. We have an internet veneer over a 1970s furniture suite.”

Can Eclinical Bust The Silos?

Waife continued: “We have powerful tools and we have a baby process that hasn’t changed much since it was born thirty years ago. This is a complete mismatch of what EDC allows you to do today. We do not take full advantage of our sites and our investigators. We are failing to re-imagine clinical development. That is what I am encouraging you to do—re-imagine clinical development.” Clinical research associates, data managers, study managers and biostatisticians are being put to Dickensian ends, he says, not given modern eclinically-savvy tasks.

Sketching what he means by eclinical, Waife lists a lot. Different clinical governance. Adaptive designs. Lower IT costs. New relationships between clinical, medical affairs and commercial colleagues. Smarter site monitoring arrangements. New protocol design practices. None of this will be easy. Or simple. But Waife argues that it will be necessary as the industry enters a looming period of troubled pipelines, see-sawing staff levels, massive patent expirations and generic competition.

For Waife, it’s clear that eclinical is not a nebulous, feel-good buzzword. Rather it is a thorough, complex reassessment of the impact of the computer on industry-sponsored research. For him, eclinical should generate better data for regulators. “Eclinical helps us get to ‘fit for analysis,’ data that are good enough,” he says. “You can use EDC to help you get to that.“

Safety: ‘Antique’

What needs to change in order to facilitate eclinical? Plenty. Waife’s firm has long emphasized process change. It is a message that still resonates. “The entire organization has to get involved with and understand what it means to be electronic, and then get behind it,” Waife says. “It’s a very challenging change management situation.”

Waife went on to suggest that other clinical trial systems warrant more attention. Take drug safety. “If you go to a drug safety department, you’ll see the most paper and antique processes,” he says. “We have a system where there is a complete mismatch between what the tool can do and how people actually work.”

Private Stash

Or clinical trial management systems (CTMS). Says Waife: “You have a problem with clinical trial management. It has been based on a linear, paper-based data source. This is all traditional paper flow. ‘I’m going to give you a place to put all this paper flow.’ Maybe you’ll type it into my application instead of a Microsoft Word or Excel application. Maybe somebody will have access to more information than they did before.”

The unfortunate thing about CTMS in practice, Waife says, is that many ordinary mortals who use such tools cultivate their own, private stashes of data for which there are no concerns about accuracy or freshness. “Everyone really uses their own Excel spreadsheet to keep track of how their work gets done,” he says. (Bayer’s Rob Musterer makes a similar argument here.)

So what would Waife see if he could wave his magic consultant wand and have big pharma do things differently?  Address the s-word. In an eclinical world, he proposes, silos of information need to be connected or maybe even demolished. Says Waife: “eclinical really is different. We need to get rid of this silo structure. This silo structure does everything it can to keep the benefits of EDC and other technologies at bay.”

‘Fit For Analysis’

Waife doesn’t sugarcoat the difficulty of connecting the silos. He believes that some innovative firms will discover the full potential of eclinical by letting small “skunk work” teams experiment, and then rolling successful efforts out to wider numbers of people across the company. The present approach, he says, ain’t working. “It absolutely cannot hold,” Waife says.

He’s not sure senior management in the pharmaceutical industry understands how to facilitate the process of moving away from paper and toward eclinical. “What we see in pharmas large and small is that the initiative is driven by upper-middle management,” says Waife. “They get the cooperation of executive management, who give a speech and disappear after a week.” A better idea, he says, is “strong, centralized leadership which is sustained. That goes a long way to people taking it seriously.”

In short, Waife believes there is still work to be done even after the current wave of EDC adoption. “What EDC and other tools bring is a flow of information in real time that we never had before,” he notes. “The information creates real opportunity and controversy over who should have access to the data and what they should do with it.”

Null Hypothesis

So his talk, in the end, had an ominous note. Some organizations are using EDC, patting themselves on the back, but unlikely to really move forward. “We know a lot of medium and large companies are very much stuck in their silos,” Waife said. “They are using all the latest tools, but they are using them really badly, because of their traditional organizational stubbornness.”

In some cases, he notes, one trial may get completed earlier, thanks to EDC. But the next trial, for a host of operational reasons, isn’t ready to start any sooner than it would have under the old way. In such circumstances, he says bluntly, “You haven’t accelerated anything.”

In the end, what made Waife’s presentation so memorable was that it fused a veteran’s acute knowledge of what industry has already done with technology—and what it might yet accomplish.