Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Quintiles has shifted its prime sites program into high gear. A bit more than two years ago, the contract research organization (CRO) had just one site designated as prime, meaning it had reached the top of the heap as a voluminous and consistent source of patients with a healthy smattering of investigators across a variety of therapeutic areas.
That was Queen Mary College, the medical school at the University of London. It got its prime-site designation in 2007. Its relationship with Quintiles was deemed strategic and included access to all major Quintiles trials.
In July of 2008, Quintiles added a second prime site: Washington Hospital Center in Washington, D.C. And last year, Quintiles added the third, University of Pretoria in South Africa. Now a fourth is coming, Quintiles says. And still others are in the pipeline.
Adam Chasse, senior director of Quintiles' prime sites program, explained that the goal is to expand the program until the CRO has prime sites dispersed around the globe in the most urgently needed therapeutic areas. Prime sites need a robust clinical research program, and the desire to grow it. Within four or five years, Quintiles hopes to have approximately 12 such relationships in place.
And the relationships do take a while to nurture—anywhere from 12 to 16 months. “We really need to take time to figure out what [the sites'] value proposition is, and make sure we can work with that particular large institution to master all the complexities inherent in doing something as pioneering as this," Chasse says.
“We learned quickly that it's challenging for a large CRO to work with a very large hospital,” he says. “There's bureaucracy on both sides; it takes time to really create the right culture of interacting differently, and then filtering it down several layers.”
What has been helpful, says Chasse, is having a Quintiles employee at the sites full time (or nearly full time), working within the hospital or medical school's clinical trials unit, spending the day focusing on everything from finding the right studies, to resolving minor delays, to doing long-term business planning. That person is dubbed the “alliance manager.”
For now, each alliance manager has had a nursing background and a solid foundation in project management. It's conceivable that Quintiles might place more than one staffer at each prime site in the future, but that's not the plan yet, says Chasse. There is no escaping the size of the huge institutions in the Quintiles program. But the closer ties allow some of the bureaucratic impediments to be removed.
“We have senior administrators who are working on my team to cut through that red tape, to streamline contract negotiations,” says Chasse. “If we want to work with each other dozens of times a year, we have to find a way to move the needle to do things more efficiently in a way that's unprecedented. It doesn't work if we don't have that commitment from the top.”
Quintiles has done about 30 studies with the Queen Mary College and Washington Hospital Center sites. Study start-up times among prime sites are about 30 percent faster than start up at other sites, Chasse says. The plan is to have the prime sites working on virtually every Quintiles study, with each site bringing in “several hundred patients” per year, says Chasse, adding, “High enrollment, studies done in a quality manner, with P.I.s who are well trained—that's the goal.”
Should smaller sites fear such large sites? Will they be taking work away from smaller participants in the research process? “I don't believe so,” says Chasse. “The appeal of these is not just that they can do the studies, but that they can do them in a much broader range of therapeutic specialties, many of which have to be done in a hospital setting.”
About three and a half full-time equivalent employees work exclusively on the program. That will likely increase soon, says Chasse. Prime sites are not obligated to work exclusively with Quintiles; they're free to take other studies from other sponsors or CROs. But should another CRO attempt to forge a similarly deep and far-reaching relationship with Quintiles' prime sites, that probably wouldn't work, says Chasse—just due to the sheer volume of work that Quintiles supplies.
Access to Patients
“We're talking about institutions where we eventually are placing virtually every study we do with them, and that means there's a lot of capacity [of theirs] that needs to be replaced with our studies,” says Chasse. The goal is to create a win-win situation. “Ultimately, we want to be able to help the institution grow their research arm,” he says. “That helps their own patient community and gives them more experience as investigators—which in turn benefits us.”
Quintiles prime sites program is part of Access to Patients, the company's site-relationship program launched in 2004. (Here's an earlier story we wrote on that.) Prime sites is the top tier, and just below that are the so-called partner sites.
Karen Nowatkoski, senior director of Access to Patients, explains that of the approximately 10,000 sites Quintiles works with, there are about 3,000 partner sites. These are the sites deemed promising and worthy of more resources from the CRO.
They don't all get their own alliance manager, like the prime sites, but those that could really benefit from having a Quintiles staffer on site throughout a study can obtain one. Nowatkoski says there are about 60 such Quintiles employees in the field at any given time, and each stays within a geographic region. “They make sure the site has a preview into the upcoming portfolio of studies, and they drive as much work as they can to the site,” says Nowatkoski.
Quintiles is trying to make its relationships with top-producing sites—both prime and partner—so smooth, pleasant and fruitful, that sites become less interested in working with anyone else. Says Nowatkoski, “If you're an investigator, wouldn't you rather work on five studies with one company and have all the operational efficiencies inherent in that, than working on five studies with five different companies, each with different staff and contracting?”
—by Suz Redfearn