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


VAILLANT: The other reason pharma really hasn't adopted EDC as quickly as other industries is that there's really no burning business need. Paper works fine and our business isn't going to fold because we need to transition.

BROWN STAFFORD: I do think one of the barriers to success has been the slow pickup in terms of the clinical monitors, because since they've been around, they've done the same job.


Johnson & Johnson's James Tiede says getting everyone on board for EDC implementation is a challenge because the existing systems are acceptable.
OLSEN: A challenge for us as an industry deals with the investigators: We all use the same ones in similar trials, so what technology each of us exposes to the investigator staff looks very different. They see one from GSK, one from BMS, one from Quintiles, and they wonder why the processes are different. They're the ultimate customers here, and it's a struggle in some cases.

How do investigators feel about EDC?

BROWN STAFFORD: For the most part, they've bought into EDC. Most of the investigators that we interface with say, once they've used an EDC product, they don't want to go back to paper. The issue now is consolidation in terms of the technology because the investigators are clear, at least from what we've seen, that they're ready for EDC.

TYSON: Four years ago when I was talking to people about EDC, the attitude I would sometimes hear was, "Well, maybe it's just a fad." Now when you talk to people about EDC, they say, "We're not there yet, but we're piloting." That's an important sea change driven by the investigators, since they've started to embrace the technology.

CHIN: It gets to the point of just trying to enhance the user experience. There's technology overload at some of the sites so there's a lot of anxiety out there. The question is: How do we make it better for them?

You have all implemented EDC, and we heard what challenges you've faced in the process. What are some things you did well, and what are the things you wished you did differently?

TIEDE: Implementing is tough work. It really requires a lot of focus, dedication, commitment from the top of the organization, and then a lot of follow-through. For us, it was a real cross-functional and multidisciplinary effort, where we spent over a year talking about the process and roles before we even began our first trial. We put the thought in it and it really turned out to our benefit. For example, when our first vendor went bankrupt, we were able to change vendors. We didn't miss a single milestone with regard to new studies, and I'm convinced it was because we had a focused definition of roles and responsibility from the beginning.


Paula Brown Stafford, from Quintiles, says once investigators use an EDC product, they don't want to go back to paper.
BROWN STAFFORD: We did the very same thing. Something else that helped was the person I put in charge of the cross-functional implementation team. I didn't want someone from data, from clinical, and I didn't want a project manager. I chose a biostatistician because I wanted an unbiased, third-party opinion within the company that could lead this implementation effort and not have the baggage of "this is the way we've always done it." It helped us be very successful in terms of setting our processes, training, pricing, and business development.


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