Last Friday, we wrote up the recent Drug Information Association (DIA) presentation by Quintiles VP of global data solutions, Thomas Grundstrom. But the ground rules of the DIA meeting bar speakers from self-promotion or advancing the messages of their employers. That left us with a few unanswered questions.
Grundstrom was happy to address those in a conversation after the conference. Unbeknownst to us, the top contract research organization (CRO) is on the verge of launching a huge new eclinical system to combine all of the major types of data in clinical trials. The system is designed to tackle an Olympian challenge: monitoring and delivering quality in industry-driven clinical projects.
Called Quintiles Infosario, the web-based software sounds like it could address FDA concerns about CROs and provide sponsors an integrated view of information about individual subjects and subgroups of patients. We've not seen a demo, but it appears that the system can pull together data from systems for electronic data capture (EDC), electrocardiograms (ECG), patient diaries, central labs, patient recruitment, data management, and pharmacovigilance.
"It's not just about the data," says Grundstrom. "It's about the integration and near real time access. It's converting that data to actionable knowledge."
One of the pillars of quality, as defined by Quintiles, is patient safety. Grundstrom says sponsor or CRO personnel will be able to use the new system to have visibility into multiple types of data about the same patient. In theory, that should allow safety issues to become apparent earlier. Rather than scramble into crisis mode as safety problems emerge, the users of the system could be proactive, even stopping trials in mid-study or notifying regulators as necessary.
Grundstrom sketches a hypothetical example to make the point. Perhaps the numbers on a patient's lipid test are outside a stipulated range. A few clicks of the mouse later, and a trend appears. "Oh, my goodness, it looks like those are females over 50. Oh, the concomitant medications seem to be in this particular drug class," he says. Drilling farther into the data, the sponsor or the CRO could review the thorough QT intervals for that cohort of patients. Says Grundstrom: "You start to now be able to do patient safety trending long before the data is locked. You can get access to this information as quickly as you need to."
Within Quintiles, for company employees, the system currently shows all trials the company is conducting. But according to Grundstrom, a few sponsor-customers of Quintiles are able to see their own trials via the internet. They're helping Quintiles develop the system. "It's not vaporware," he insists. "It's very much a reality."
By early 2011, he hinted, the platform will be ready for prime time and more customers will be able to access it. The Infosario system already has a nightly feed of electronic data capture (EDC) data from selected Phase Forward projects, something Grundstrom is clearly proud of.
As part of developing the system, Grundstrom said the company is drinking the Clinical Data Interchange Standards Consortium (CDISC) Koolaid. He noted his boss, Paula Brown Stafford, is the chair of the organization's executive board. The firm's system has been made possible with CDISC standards, especially the ones for case report form data called CDASH. "We have a nightly feed. It's an ODM, XML, CDISC transactional feed. In a standard industry format, we get what's new and what's changed," Grundstrom says.
But Grundstrom also makes it clear that when the CDISC standards effort had gaps, the firm rolled up its sleeves to fill them. To take three specific cases, the CDISC standards didn't account for how to structure and format audit trails, data queries, or information about the status of individual bits of data. Says Grundstrom: "We have had to build the XML structures around those areas. We don't just get the data. We get the metadata as well."
Grundstrom implied that Quintiles views data integration as a high-priority component of ensuring patient safety in clinical research. He doesn't sound satisfied with the status quo in the sponsor community—a fractured, Balkanized view of a patient, with facts spread across several types of experts or corporate departments. Many CROs, he says, have the same splintered, silo-driven perspective on patients. Says Grundstrom: "The CROs have been as fragmented and siloed as the sponsors. All the databases were stored separately. All the processes were stored separately. It's amazing within most CROs how fractured and siloed they are." In addition to developing technology, the company has been studying the interactions of its people and processes.
The result is a sea change. After downplaying the importance of technology or leaving it to others, Quintiles appears to be positioning itself as an organization that is just as technologically savvy as rivals such as Parexel and i3, which have made their own efforts to integrate data, such as this and this. Companies like PharmaPros, in the Boston area, specialize in customized data integration projects for clinical trials.
In a later version of Quintiles Infosario, Grundstrom said, the trial protocol and other unstructured data will be available. That would allow someone with the right access privileges to dip into a document management system, find the protocol in a Microsoft Word file, and explore the origins of a safety issue in the trial's inclusion and exclusion criteria.
Down the road, Quintiles is thinking even larger. It's watching the CDISC effort to structure trial protocols using XML. This may mean that protocols could be handled by computers and electronically zapped between systems and organizations. "There won't be any need any more to go look at that copy of the protocol," Grundstrom says. "The source document itself will be part of the database."
Grundstrom believes the CRO's Infosario technology will not merely be yet another system. With a bit of the evangelist fervor of a software vendor, he believes it should be possible to present sites with a query just once, no matter how many disparate systems it might be tangentially referenced in.
After resolving the query, it would be well and truly closed—not arise, like a vampire, to torment the site indefinitely. Says Grundstrom: "[The sites] never ever see that query again. I would have people kissing my feet. It is not simply just reporting. It is a way to revolutionize drug development."
Editor's note: Here is an earlier article on Grundstrom from last week. He's presenting and moderating at the Society for Clinical Data Management (SCDM) 2010 annual meeting in Minneapolis from October 17-20.d9A2t49mkex