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


TIEDE: One of the things we need to look at is, once we've done our first and second trial, who do we need to go back and certify? We're trying to build an internal database of those who have been through the experience, so we don't have to give them all the same training every time we do a trial, especially on the technology side.

VAILLANT: The success or failure of EDC is not going to be dictated by the technology. It's going to be dictated by the support infrastructure you put behind the technology, including training. I think CRAs [clinical research associates] really shift their focus from being data cleaners and data checkers to being relationship managers. That's really where their time is better spent. We're changing from an organization of viewers to an organization of managers. We're no longer doing the work. We need to develop a skill set to manage the work more effectively, which means having more project management skills.

You're talking about redefining roles. Can you talk a bit more about this idea of roles and how they can change? What about the people who have to deal with remote locations, like the monitors?


Tyson, says managers must be patient if they want to see the benefits of EDC.
TYSON: Monitors can have 100 percent visibility of the data, so when they show up, everything's ready to roll—we see what a significant savings that is. That's a huge power to give to the monitors, and it's totally different from the past when they had to do the best they could with what they had. Now their job is an ongoing site relationship and data management role. The day-to-day interaction is a whole new role for them.

The needs of the medical monitors, however, aren't the same in every company. It depends on the therapeutic area and specialty. So it points out a new core capability that clinical IT needs to have. This is a challenge because not all organizations have clinical IT, and not all IT organizations specialize in clinical trials, yet it's what clinical needs.

BROWN STAFFORD: What we are seeing is that the monitors still are going to the sites almost as frequently because they have to monitor the safety of patients and make sure investigators are following good clinical practice. But the difference is the time on-site isn't spent in query resolution and cleaning data, because that's happening before they go to the site through the data managers.

TIEDE: Yes, the time on-site is much more productive and focused on the relationship between the monitor and the investigator—time spent data cleaning has decreased significantly. It's all accessible online, so they can see what the status is, where the issues are, if people are getting behind. To the extent one builds as much front-end loading as you can, what we've seen is up to a ten-fold reduction in queries. That's where the greater efficiency comes in. They want to be able to look at all the trial and patient information on a dashboard, which to me is great. I love that people are beginning to think that way.

BROWN STAFFORD: We're changing the way we train our monitors. We ran our first trial in 2000 and now we've just put into production our 200th EDC trial. We have an enormous amount of experience, but through that phase for clinical monitors, EDC was still an initiative. They came into Quintiles and wanted to receive the general CRA training within Quintiles, which really had no EDC component. It was only after you were allocated to an EDC study that you were trained. So what we did was put an e-CRA certification process together. This has changed recently because it's not an initiative anymore. It's mainstream, so we have to certify CRAs to be e-ready and not wait until they're assigned to a new study.


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Source: Pharmaceutical Executive,
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