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
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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.
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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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