Being an analyst in the life sciences is a bit like being a diplomat to a Scandinavian country. There’s not always a lot to alert the home office about. The landscape is a glacial, treeless expanse where change is almost imperceptible.
Except that of late, Carol Rozwell, research vice president, life sciences, at Gartner, reports the glaciers are dancing. Rozwell is as genial and sharp-eyed an observer of technology trends as you’re likely to meet. She says most CIOs have budgets with single-digit percentage increases to work with. And data standards are coming.
Rozwell recently used Gartner models and her own estimates to calculate what process improvements and data standards might save the industry: $5.8 to $6.6 billion annually. That is the entire R&D budget of a large pharma. How could the figure be so large? Rozwell takes a deep breath and tries to speak as diplomatically as possible. “We know there’s room for improvement,” she says of the pharmaceutical industry’s on-again, off-again flirtation with technology.
Rozwell presented her numbers at the 2005 Drug Information Association’s annual meeting. She’s been encouraged by real change afoot. “Traditionally, we have thought that life science companies were technologically conservative,” says Rozwell. “There really does seem to be a renewed interest in how life science companies can use technology to support improved business practices and improve consistency. That’s not something that we would have said two years ago.”
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That progress includes electronic data capture. “I’m starting to see some clients who are admitting enterprise-wide deployments of EDC and electronic patient-reported outcome systems,” says Rozwell. “I can’t get anyone to talk about it on the record. That tells me they’re in the early stages. They’re expecting that technology will give them an edge.”
She says there has been a wide acceptance of the benefits of standards, with or without full support of all vendors. “I’m encouraged by how much progress has been made in the adoption and implementation of standards,” she says. “Standards have now become more acceptable as means of improving business performance.” She gently corrects a reporter about a schism between large and small vendors supporting standards, praising SAS’s wholehearted support of CDISC.
Rozwell is not at liberty to name too many names. But she says Wyeth’s unusually detailed accounts (at DIA and elsewhere) of its own reorganization is the prime example of technology and science coming together adroitly for higher productivity. Wyeth is not the only case, she says: “We definitely have had a number of calls from clients that are making major changes in clinical trials processes.”
Will there be a return on investment for vendors getting on the CDISC bandwagon? Says Rozwell: “We know that the vendors that are truly supporting the CDISC standards-as opposed to those that just state that they can deal with standards-those vendors should be seeing an advantage now. That advantage should continue over the next few years. Are we at a tipping point? We’re at a tipping point or very close to it.”
Rozwell seems doubtful that the FDA would formally mandate the CDISC standards any time soon. “While the FDA might not mandate standards usage,” says Rozwell, “they are strongly encouraging the use of standards. That’s pretty undisputed.”
Rozwell declines to speculate on the impact of the Vioxx lawsuits on technology adoption, lamenting the public hue and cry about Merck. But she says it’s plain to everyone in the industry that a clinical trial alone will not tell a sponsor or a regulatory agency everything it needs to know. Says Rozwell: “What this does point to is the opportunity to do better data collection when drugs are on the market and better analysis of that data. You can call that data mining. We can know more. And we can know better, faster, with the use of the technology.”
Still, she can’t resist a hypothetical scenario once Vioxx or something like it had been approved for the market. “What if they used e-detailing and they really went out and made sure the physician truly understood what the studies told them about safety? And they also combined that message with some patient-oriented literature? A lot of the material supplied to patients defies interpretation, even to college-educated people. If they had done those two things, there’s no telling what the impact would have been.”
In Gartner’s recent survey of life-science chief information officers, she notes, some top-of-mind concerns overlap with other major industries. Some are unique. With pharma and biotech companies, one of the looming issues is … the envelope, please … enabling a mobile workforce. “Merely automating the sales force is not a competitive advantage,” says Rozwell. “What life science organizations have to focus on is making a smaller sales force more effective.”
Date: February 25, 2019
Source: Bio IT World