It's Standards Time - Pharmaceutical Executive


It's Standards Time
Pharma does EDC in clinical trials, but is anyone doing it right?

Pharmaceutical Executive

"We recognized that we were having some technical challenges," says Steven Olsen, former EDC business leader at Bristol-Meyers Squibb. "We reached out to three of the other large companies and said, 'Can we talk about our shared investment in this technology?' And we did. We went to Oracle and said, 'Look, we're all struggling in this area. What can you do with us?' And Oracle has now committed to giving its entire client base a new user interface, one that is going to be a much better experience for the site staff about two years earlier than it had planned."

Pharma EDC task groups, coalitions, and open-information-sharing sessions, like those found at the DIA conference, also are making it easier for pharma companies to understand how their systems work and how they affect those who work with the systems, according to industry experts.

"I think standards are going to start to play in over the next five years as pharma companies begin to tap into electronic health records," Olsen says. "Little things like passwords and log-ins can also get confusing when a doctor has to remember them for 20 different technologies running on six different systems."

Doing EDC Right

In the meantime, it's up to individual companies to streamline their electronic processes. According to Campbell Alliance's Tyson, if a company is going to set EDC as a standard, then it has to pick no more than one system and a backup. A company must also select a system that not only meets its needs today but also will meet its needs in the future—across multiple therapeutic areas.

Some tips:

Ease in "Campbell's advice is not to go cold turkey, where you just go from 100 percent paper to 100 percent EDC, but to transition the system over time so that people can get familiar with it," Tyson says. "Then pick one vendor, and stick with it and invest in building a standards library."

Watch the work flow It's important keep in mind that work that was done post-live in a paper environment now has to get done before a trial starts. For example, all databases must be built before the study goes live so that the information from the electronic case report form has somewhere to go.

Decide whether to rent or build Companies need to determine whether they want to work with vendors or create their own EDC tools. The first scenario involves no real commitment and can be used on a study-by-study basis. The vendor builds the system, hosts it in its own EDC environment, and the trial outcomes are nicely packaged for the pharma company at the end of the day. "If you're doing EDC on a study-by-study basis, you could work with three or four different vendors," Tyson says. "It's just done on a one-off, 'who do I feel like working with today?' basis by the various study managers."

Most Big Pharma companies, however, have grown out of the experimental phase. In the last three years, they have realized that if they're going to get real organizational value from EDC, they need to embrace it as a standard in all studies going forward.

Adapting to Change

One area that is really benefiting from EDC is adaptive-trial design. "The whole theory of adaptive-trial design wouldn't work if you didn't have electronic data capture because of the delays associated with getting the data in from a paper-based study," Tyson says.

To Glen de Vries, chief technology officer at EDC provider Medidata, the point of adaptive trials is to allow faster decision making: "With adaptive clinical trials, people are finally saying, 'The processes that we've had to date are not letting us make decisions as quickly as possible. Let's look at new statistical methods. Let's look at new processes,'" he says.


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