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


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

There's the axiom, "If it ain't broke, don't fix it." I think some of our readers, from pharma execs to investigators, need to understand why role changes matter. How do you convince them that EDC is the next wave of the future when the paper process has worked for them in the past?

Steve Olsen
TIEDE: Sometimes you have to put [in] lots of effort to convince the skeptics early on, but once they see the benefit, they become the strongest advocates. That's what helped Centocor move from doing everything in paper to essentially putting everything out with EDC in three years.

Building success and being able to relate it as a story to the new teams helps get others on board. People get concerned when out of the 40-odd trials we've done, we've only made nine submissions. I don't want to do this on a submission study because there's too much at stake, so I build a story on the fact that the nine submissions we have made have all been successful. Early on, you really have to be out there advocating and really trying to convince the people we have our ducks in order, and that we're going to follow through on our commitments and make it a success.

OLSEN: Last December, we had a global team over with our clinical operations group for the first time in several years. We had to work hand-in-glove with them to get it going, but once the project manager stood up in a meeting of 600 and said, "I just entered information for first patient/first visits and I already have data in my database," it was fabulous. That's the reward that you get. At a meeting where a peer said it was worth the pain? You can't buy that publicity.

In the end, we wound up with an internal government structure that we've been able to tap into. It's not just the EDC team that needs this. The entire organization needs it. All of a sudden, the light went on that indicated we were serious about this—it's now baked into the process and allowed us to move to the next level. We've progressed 25 to 75 percent this year, and teams are coming to us because they want to be part of this. Last year it was pulling teeth just to get the early adopters on board.

It seems that what you're trying to do is reinvent a lot of existing pieces by leveraging the technology and bringing the knowledge work to the forefront. In the long run, what parts do you think will benefit your company?

VAILLANT: One of the things I experienced is that implementing EDC forces the organization to look at protocol development very carefully and the actual data you're collecting. In the paper world, it's okay to collect everything "just in case." And we hear that all the time: "Well, we want the data just in case." In EDC, it's a little more difficult to make that just-in-case scenario work. You need to be very, very careful about what data you collect. You need to be very discreet.

TIEDE: One thing we did post-implementation that really helped was to create an e-clerical steering committee. We had people from the therapeutic area, data management, and trial management. This was kind of a standing group that served as a clearinghouse for issues, and also has been used to promote further development.

CHIN: When it really comes down to building a clinical trial, it's quality by design. Now people are being forced to think up front, design up front, invest up front. So you're front-end loading the entire process. We have to hit this timeline, and push a lot of activity not only in the trial design, but also in training our staff and supplying the sites.


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