Routine as it is to use electronic data capture (EDC), it is still instructive to overhear the thinking of an organization in using a new tool. The slate was wiped clean at Hospira, a pharmaceutical and medication delivery company that was spun out of Abbott Laboratories in 2004. The new company had 15,000 employees but no legacy clinical trial technology systems of any kind.

Which is interesting. Baggage—institutional and psychological baggage—is a common part of the decision to adopt any new technology in any industry. What didn’t work in the past? What have you already tried? How many old processes have to be carried forward into the new era?

Hospira, as best we can tell, did not have much baggage. It did need a platform to support 6-10 clinical trials in 2007. For future studies, the company expects that all trials will use EDC.

A Happy Transition

When we spoke with Jeremy Jokinen some time ago, he was Hospira’s director of biostatistics and data management. He’s since moved on to Statking Consulting, where he serves as director of statistics and data management.

Jokinen says Hospira’s selection process began as a search for a data management vendor. The company had no internal systems for data management. But then it realized such systems might not position the company well in the future. Or be affordable.

Focus On Cost

Says Jokinen: “We started to realize that paper-based systems really weren’t going to work well for Hospira because of the costs.  We were going to be in a position where we were going to require a number of data entry personnel. We were going to require a lot of IT staff for upkeep of that type of system. And we began looking at other options.”

The search turned to EDC, but that was not a risk-free proposition. An early experience with the technology had left a bad taste in the mouth of some of its investigators and their clinical research associates (CRAs). Naturally, the company wanted to avoid that going forward.

And there was the Philippine connection. The company was considering a data management operation in Manila, and wanted an EDC solution that would be completely accessible over the web. What’s more, the company’s pipeline of trials was in flux, meaning it did not want to make a large upfront commitment to a specific number of projects.

Pockets of Resistance

Says Jokinen: “We needed a flexible solution, both technologically and from a financial standpoint, something that would allow us to consider our trial pipeline on a study-by-study basis.” To make a long story short, Hospira chose DataTrak International, out of Cleveland.

Jokinen says the technology is being eagerly adopted by the Hospira project managers, facilitating a faster transition than originally anticipated. Indeed, some of the skeptics about the technology are now angling to be able to use it, even on the more complex studies that Hospira had first expected. “They’ve seen how the information is available to the project managers who are using the EDC system and, quite frankly, they’re a little envious,” says Jokinen.

A New Mindset

What’s more, the project managers using paper are feeling at a disadvantage, in part due to pressure from senior managers. Says Jokinen: “The project managers who were responsible for the studies that don’t have the access to information are now held to sometimes an impossible standard by upper management, because upper management is starting to get used to the immediate access to study metadata, to study status that they get with the EDC system.”

The question of what EDC costs is often complex. So is the tabulation of the dollars needed for alternatives to EDC. Jokinen notes that Hospira went through a surprisingly even-handed accounting exercise for technology adoption, facing its IT staffing needs should it develop EDC internally. It also considered what it might cost to give the work to a large contract research organization.  “We really needed to identify some areas where we could save some money,” says Jokinen.

In the end, Jokinen estimates,  the application service provider (ASP) approach will offer significant savings. “We believe that compared to CRO outsourcing for data management services, we will save roughly 30 to 40 percent of the cost of what we expected to spend on CROs. That includes the upfront and the implementation costs.”

Dedicated To DataTrak

Part of the financial success, Jokinen reports, can be attributed to the performance of the selected vendor. “We’ve been so successful with the implementation, and I really credit the DataTrak team,” he notes. “They’ve been so thorough in getting the project management teams on board and in getting regulatory groups on board that that’s really what has allowed us to implement the EDC solution across a greater number of projects and, therefore, expect a larger savings than had we simply implemented it on a more conservative basis.”

Jokinen stresses that the technology may have more far-reaching consequences than some people expect. “EDC is more than just a data management task,” he says. “It’s a task that affects how all of the different functions within clinical research operate. To the extent that our vendor, our partner, was going to be able to bring these other functional areas on board to help us sell this entire initiative, we knew that it was going to be successful.”

Reaping The Rewards

Indeed, he says some companies in the industry may not be positioning themselves to harvest the potential savings or efficiencies from EDC. The best intentions for the usage of technology may come to naught if the technology and the rest of the clinical trial process are not well-matched.

Project managers, Jokinen believes, are part of that pairing. They should be involved in the early discussions of how to use EDC. The issue is: there will be new information in the system; how will that alter the existing paper-based process?

Says Jokinen: “To really make use of the technology and all of the advantages that EDC can bring depends upon project managers understanding how their jobs will change. You could, I believe, implement an EDC solution and really experience none of the benefit because you fail to alter how monitoring is conducted. You fail to alter how reporting is done internally, and you really wouldn’t reap the benefits of EDC.”

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