Roundtable: Are We There Yet? How About Now? Now? - Pharmaceutical Executive

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Roundtable: Are We There Yet? How About Now? Now?
Can Electronic Data Capture become the industry standard for clinical trials? In this roundtable discussion, six early adopters reveal where they struggled, and what you need to know to implement this new technology.


Pharmaceutical Executive



Gary Tyson, vice president, clinical development practice at Campbell Alliance
Electronic data capture (EDC) is an emerging paradigm for gathering information in clinical trials. Ask anyone who has sorted through stacks of accumulated paper at the end of a study, and they'll say EDC is the wave of the future. But while many companies are on board with the technological benefits, enthusiasm wanes when it comes to actual implementation. Even some of EDC's biggest champions admit to its obstacles: "It's a disruptive technology that doesn't give immediate returns," says James Tiede, vice president of integrated data services, global clinical operations at Johnson & Johnson.

Tiede is one of several industry executives who gathered to discuss companies' obstacles for full-blown EDC implementation—and also to examine the technology's benefits. Hosted by Pharmaceutical Executive and management consultancy Campbell Alliance, the executive roundtable brought together a group of early EDC adopters, all of whom had offered thought leadership to the industry and their company in pushing forward the technology.

The conversation was moderated by Pharm Exec's editor-in-chief Patrick Clinton.


Ted Chin, vice president for electronic data management at GlaxoSmithKline
Along with J&J's Tiede, Clinton was joined by Kelly Vaillant, global head, clinical data management at Amgen (attending via speaker phone); Steven Olsen, associate director, global development and informatics at Bristol-Myers Squibb; Gary Tyson, vice president, clinical development practice at Campbell Alliance; Ted Chin, vice president, electronic data management at GlaxoSmithKline; and Paula Brown Stafford, executive vice president, global data management at Quintiles. The following is an edited transcript of the session.

CLINTON: Most companies know the benefits of EDC—the real-time access to data, faster study completion, and cost savings are clear. Still, some leaders are hesitant to fully integrate EDC into their organizations. Why should they integrate EDC into a clinical trials process that has worked for them for years?

TYSON: One of the messages we tell senior management is that EDC has a lot of tremendous benefits, but you have to be patient if you want to see them. You're not going to see it in year one. It's just a classic case of people needing to be aware that with any kind of major change, you have a ramp-up curve before you see any benefit.


Paula Brown Stafford, executive vice president, global data management at Quintiles
TIEDE: I agree. It's a disruptive technology that doesn't give immediate return. But through the repeated application and deployment of integrating EDC into how we do our business, that's where you get the return. That takes more than just a year.

OLSEN: If you look at the conversation at EDC conferences four years ago, everyone was saying, "Let's try it, let's pilot it." Now you go to conferences and people are saying, "I'm in this stage of an implementation," "We're at 90 percent already," or "We're in the year where we're moving from 25 to 75 percent." Companies are now in that stage where they've committed to it, and we're somewhere along a continuum of getting past the pilot and into whatever is full mutation for an organization. There's a growing understanding through our peer community and a sense of community among the pharma companies.


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