Does the pharmaceutical industry need to rethink the management of drug safety data and pharmacovigilance? A few companies already are. That was clear at this year’s annual Society For Clinical Data Management (SCDM) meeting. Appropriately, the session tried to explore the tenuous technological links between two areas of human expertise: the medical interpretation of drug safety issues and the processing of individual reports, either during a trial or after a drug has reached the market.

“We are actively doing signal detection,” noted Sue Howard, assistant director at GSK. “I would recommend that if you have the opportunity at your company to get involved with it, I would recommend you do so.”

Connected Systems

GSK says it is now able to move beyond a common practice at other firms: the tedious manual reconciliation of the primary clinical trial data with a second set of safety data. “Databases now talk to each other,” she said. “It’s 2008. We have to keep that in mind.”

Glaxo, she said, initially hesitated to automate the process. People had become accustomed to the old way of working, and wanted to hang onto it. That changed after the system was turned on. “A month after it all was rolled out, nobody felt they lost anything,” she said.

The cost of reconciling perhaps 700 adverse events a year was perhaps $29,000 for her team in the old days of paper and disconnected systems, she suggested. She didn’t know the cost of connecting the systems. But some of the benefits cannot be quantified. The end of manual reconciliation, she said, lead to greater data integrity and peace of mind. “Can I tell you how much less stress we have at database release time?” she asked. “We have more accurate data in the database. You’re now not rushing. You can identify the data trends.”

New Questions

Clearly, not every electronic data capture (EDC) and drug safety system can be connected to each other. “If you’re looking for a new EDC system, I would ask questions,” she said. “Can multiple roles ask questions? Is there a multiple linkage of forms?”

In the same session, David Handelsman, life science R&D manager at SAS, had a similarly forward-looking orientation to his remarks. But his tone was less warm and fuzzy than Howard’s. He sketched an ominous landscape of drug safety that includes high public skepticism, elevated regulatory vigilance, and law firms organized around helping plaintiffs sue the industry.

Such an environment, Handelsman said, demands new tools and approaches: “At the end of the day, keeping patients safe is what’s important. There are ways data management can help that process.” The general practice in the industry, Handelsman says, is reactive. “You need to be looking early and often,” he said. “This is fundamentally what safety is—a risk mitigation strategy. Some companies are surprised when their products appear on CNN. It makes more sense to say, ‘At my company we found a signal. It only affects patients in this category.’ ”

Haystack Management

As an example of the sort of issue the industry should attempt to be able to anticipate, he cited Flomax (tamsulosin). The prostate blockbuster turned out to have a curious complication only in patients undergoing eye surgery. Said Handelsman: “I can pretty confidently say that during the research, those patients weren’t getting cataract surgery. It’s very much a data issue. It’s a clinical issue. It’s a hard problem to solve.”

New software from SAS may be of assistance, he suggested, because it offers multiple epidemiological algorithms to sort and sift the data. Handelsman focussed on the heterogenous nature of drug safety data. The industry, he proposed, should be able to routinely tap into multiple data sources and analytical methods. The world has changed. Slowly reviewing boxfuls of paper may have unrecognized financial and reputational costs. “The data is far too complex,” says Handelsman. ”It is coming from too many sources. We have to look at the data differently.”

Editor’s note: here’s an earlier ClinPage story on SAS.

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