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

TYSON: There's a willingness to question fundamental assumptions that people have embraced since they were junior-level staff in the industry, but it's hard to do because change is hard. One of the key challenges is the willingness to look at fundamental assumptions about roles, specifically whether they are roles between the sponsor and the site. For example, in many people's minds, there's a very clear distinction between what monitors do and what data managers do. But in an EDC world, that becomes a very gray area—it becomes an arbitrary decision that has to get made. It's not dictated.

Steven Olsen, associate director, global development and informatics at Bristol-Myers Squibb
If you go with the assumption of what monitors have always done and what data managers have always done, will EDC work? Sure, but it won't work optimally, so it becomes a classic silo-breaking assumption that leaders really need to revisit. When we talk about the challenges in the industry, I think letting go of models that have worked well for new technology is hard to do, but it's critical.

CHIN: Within, at least GSK, we've made the decision to really drive EDC into our business and we've seen significant benefits: We've increased our data management capacity greater than 50 percent; we've seen queries and cycle times drop; and we've seen last patient/last visits database. Our battle lines now are drawn on integrating our clinical data, meaning all of our clinical data, not just the eCRF pieces, labs, X-rays, PET scans, and pharmacogenomic data. Query turnaround time is very fast and costs have come down. It's truly beginning to drive a very different way of looking at the data and making inferences of that data.

There is a major issue of cost versus benefits, because this is a process where the real benefits are downstream. In a business that values immediate return on investment, what are some of the improvements that outweigh the initial cost of implementing EDC?

James Tiede, vice president and head, integrated data services, global clinical operations at Johnson & Johnson.
TIEDE: We've tracked this within Centocor [J&J's research and clinical development organization] and we literally saw a ten-fold reduction of queries. We saw a three-fold reduction in the time to resolve queries, and more than a 60-percent reduction of database lock. Over the time we were tracking things, we increased our capacity and estimated that we avoided hiring 28 people over four years.

OLSEN: You're deploying a new technology so you have to put a help desk in place, as well as provide different training for the help staff and investigator staff. At least in my organization, folks are saying, "We didn't realize it was going to cost us that much to do this type of thing." But for us at BMS, there are fewer discrepancies within the tool that we actually have to manage. This is a big benefit. The organization has become much more efficient, as well. The teams are now becoming 20 to 40 percent more efficient.

What stands in the way of EDC becoming the industry standard for all clinical trials?

TIEDE: A lot of it is a management issue. EDC is redefining how companies do business and a lot of us are deeply embedded in legacy systems. The existing processing systems are fine and everybody's comfortable with them, so changing it and trying to deal with that risk is a challenge.

CHIN: I agree. You need to have the senior management commitment of vision of where you want to take the business. At GSK, the hammer went down from up top, and it took that commitment and vision to be able to really drive it into our business.


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