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

CHIN: GSK took a very aggressive approach to driving EDC into the business, with senior management well behind us. They gave the team a very aggressive target, which was to have at least 80 percent of our new clinical trials [using EDC] by the end of 2005. And here it was, mid-2004—we had 18 months to look at the entire organization. But that vision and commitment led to a very focused purpose and we drove this thing unbelievably hard. We did manage to deliver, not only 80 percent, but 90 percent of our studies by the end of 2005 that were across Phase I to Phase IV.

TYSON: In the end, aggressive deadlines focus resources, and that's why we're in favor of them. And like anything else in life, if you have an aggressive deadline, you can pull yourself up in the priority list and you can get the resources that you need to get it done. Without deadlines for organizational adoption, you get into a pilot-forever mode and you never see any benefit from EDC because no one really learns to work differently.

TIEDE: I didn't use the word pilot when we rolled out because to me, pilot doesn't give the sense of commitment. For us, it was deployment. I wanted to tell the organization that, in fact, we were making a change and we were not going to go back if the first one didn't work. This was the first step of a continuum.

You would think the biggest danger in the implementation is that you would go halfway—you replace the paper, but wouldn't fix or rebuild processes. How do you keep that from happening?

TIEDE: I can't tell you the number of times we've talked to organizations that have gotten the ball within ten yards of the goal, but for whatever reason couldn't get it over the goal line because they lost their focus on the training. It requires as much energy and as much focus as the "cool" re-engineering stuff, and it's where some organizations really struggle.

CHIN: Training really has evolved from an old world, where you put a factory worker on an assembly line and you train them to do these things. But these are tacit knowledge workers, so what we actually have to do is re-skill. Training is the onus of the company and re-skilling is our onus. These are the skills that allow you to be able to survive and really thrive in this 21st century. We also have to train investigators in ePRO [electronic patient reported outcomes] and all the other technology out there. [Investigators] are the part and parcel of driving this EDC continuum.

OLSEN: I have a specific example: We have a large EDC study that has high visibility in the organization. We had an investigator complain to us that our EDC tool wasn't as good as somebody else's and we weren't ready for ePRO yet. This guy had an e-tool that he had to learn and be trained on, yet he still had to use his black pen and a piece of paper. We felt a little bit schizophrenic about how we presented ourselves to the investigator. Just one of our studies requires six to nine hours of training time, so we're really putting a burden on our investigators—you can see why training them properly is important. They're the ultimate user.


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Source: Pharmaceutical Executive,
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