The company on trail for liability around its now-defunct painkiller Vioxx is hoping a business intelligence software product could provide some relief to the drug development process.
Merck & Co. has spent the past four years
searching for a common analysis and reporting platform its biostatistics and research division can use to process clinical trial data from several different software programs. The chosen platform will have not only have to present that data in safety tables but comply with the growing range of regulatory standards that govern the drug development industry.
So far, SAS Institute Inc. has emerged as one of the few contenders for the project, according to Merck Biostatistics and Research Decision Sciences Organization vice-president Ray Bain. Bain was among the executives on hand at this week’s SAS User Group International conference in Philadelphia, where the company launched its Drug Development 3.0 software.
“We’re probably looking for version 3.1 to be where we want them to be,” Bain said. “We’re getting more comfortable with it, but what’s really been impressive is a sea change in which SAS has been willing to learn more about how we do things. Our own IT organization hasn’t done that.”
Managing clinical trial data and complying with regulators is an important issue for Merck, which last September pulled Vioxx after it was linked to an increased risk of heart attacks and strokes. The company faces billions in liability claims but has promised to defend itself. On Wednesday Merck asked a judge to dismiss the first Vioxx trial after accusing the plaintiff in the case of lying about when the pills were sent to her.
Merck already uses SAS to manage about 80 per cent of its clinical trial data, from Phase I evaluations of compounds through post-marketing, but the rest comes from other vendors. The early versions of Drug Development didn’t meet the firm’s needs, Bain said, because it would only guarantee standards compliance for other SAS software, not third-party applications.
“(SAS) is the backbone of our analysis,” he said, “but if we were to be 100 per cent SAS we would feel like we were not differentiating ourselves in terms of statistical innovation.”
Laurie Rose, SAS’s director of health and life sciences, said the Vioxx recall has affected the public perception of the pharmaceutical industry, which has become highly competitive as firms use commercials that urge patients to ask their doctors about new drugs. SAS is a board member of the Clinical Data Industry Standards Consortium (CDISC), and has tried with Drug Development 3.0 to create a central repository for information that will speed up the process by which drugs are submitted to authorities like the U.S. Food and Drug Administration (FDA), she said.
“What we want to do is get away from the 18-wheeler trucks full of boxes,” she said. “That’s not an exaggeration – that’s how this stuff would be sent out.”
Part of Merck’s problem is that it stores much of its data in a custom-built database, Bain said. The information inside may be compliant with FDA regulations such as 21 CFR Part 11, but extracting it raised quality assurance concerns and wasted time.
“You’d take a couple of coffee breaks and wait for it to churn,” he said. “Our IT people were focused on getting the information into the database, but we also need it out, analyzed and sent to the regulatory agencies.”
Pharmaceutical firms find the data management issue particularly tough because many of them grow by acquisition, Rose noted, which means a slew of disparate systems and processes. Even though Merck hasn’t signed up for Drug Development 3.0 yet, she said it should be well received by the many companies that already submit much of their clinical trial information as SAS data sets.
“It’s hard to quantity what it will mean in terms of faster time to market,” she said, adding it can take many years and more than US$1 billion to get drugs on pharmacists’ shelves. “This is really about the need to improve the way data is shared.”
SAS Drug Development customers so far include Solvay Pharmaceuticals, which uses it to provide information access to about 100 researchers around the world, Rose added.
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