As with caterpillars and butterflies, there has been a metamorphosis in attitudes to technology inside the contract research organization (CRO) industry.

In the first stage, CRO representatives stood up at conferences and said, more or less: Technology? Huh? Now? Why?

In the wake of an intriguing ediary partnership between Quintiles and invivodata, at least one big CRO is demonstrating an evolved understanding of technology. The new message boils down to: Our patient-reported outcomes (PRO) teams and our processes are tuned to work with those of invivodata. If you use both of us, we can avoid the headaches associated with managing multiple vendors and data streams. The partnership raises a possibility of PRO projects being launched on a larger scale, a more routine basis, than is now the case.

EDC Parallels

In a recent conversation with Paula Brown Stafford, executive VP of integrated clinical services at Quintiles, she was too modest to mention a recent honor: she was named to chair the board of the Clinical Data Interchange Standards Consortium (CDISC).

She sees parallels between the industry's gradual appreciation of electronic data capture (EDC) and the PRO niche. The big CRO now uses EDC on 75 percent of its studies, she says. A similar shift from paper-based PRO projects is taking shape. "We do see our PRO studies going to the electronic version," she says. Smart sponsors want the cleaner data that electronic modalities can yield.

Brown Stafford adds that selecting invivodata as a preferred provider was a difficult call. The precedent, she reports, was picking Phase Forward as a top EDC provider. Brown Stafford says there are many high-quality PRO providers in the industry. And just as Quintiles routinely works with multiple EDC suppliers, it will continue to honor requests from sponsors that ask Quintiles to work with other ediary suppliers, companies that include PHT and CRF.

With a rueful tone, however, Brown Stafford also relates that Quintiles has selectively turned down a few EDC projects in situations where a lesser-known, sponsor-selected technology supplier was too much trouble. That's not so much a critique of any particular vendor, but a recognition of the learning curve to getting services and technology to mix well. That's not an issue with invivodata and Quintiles, where the relevant project teams have collaborated on 20 trials at 1,500 global sites with more than 10,000 patients.

One Presence

Brown Stafford says the two companies enjoy multiple communication conduits--on software and human levels--that will not need to be sewn together from scratch for each project. The lesson for the rest of the industry might be not merely to use technology, but to dance with your partner so smoothly that, by outward appearances, multiple organizations function as one entity.

"When you can put a structure around alliance management and you're not managing one-off projects, you improve that relationship," Brown Stafford says. "That's what we do with these types of relationships. The more our staff get acquainted with one provider, we provide a more quality service. Quintiles is in a unique position to be able to bring all of these sources together and integrate them in a faster time frame." The top CRO is currently assessing imaging providers to find a preferred partner in that arena.

Relationship Management

And sponsors? She hints they are weary of keeping tabs on a fluctuating roster of technology and service providers for each project. (That's what sponsors typically insist they need, of course.) One way to avoid a mob of newly-acquainted providers of services and technology, according to Brown Stafford, is to be sure the teams are pretty comfortable and familiar with each other over multiple trials. "There is a different skill set for managing vendors than managing science," she says. "I don't want to ask my staff to learn a new technology. There is more room for error and therefore decreasing the level of quality. We're trying to take the onus off of sponsors developing a relationship with each of the different sources."

Brown Stafford adds that she is surprised about the industry's ongoing reliance on the paper diary. "There is a bit too much paper out there," she concedes. It doesn't sound like she needs to ruminate on the benefits of an electronic method to capture patient experiences. "I love the fact that it date stamps when the patient entered that data," she says.

Like patients preparing for a visit to the doctor, Stafford Brown's young children put a lot more effort into their music lessons on the night before seeing the teacher. The youngsters solemnly tell their teachers that they have practiced all week, just as patients with paper diaries solemnly claim to have made daily records of their symptoms. "It's human nature," she says. "We want to comply. But if we're given that room to not comply, that's what is going to happen."

Education Needed

At the sponsor level, Brown Stafford says, there is interest in the usage of PRO in central nervous system disorders, in gastrointestinal conditions. But not in oncology. PRO instruments are not yet automatically included as part of every clinical protocol or program. Ediaries have been used to prove a primary endpoint in only a few circumstances, she says. But Brown Stafford thinks the level of awareness of PRO will slowly shift.

One reason for that, of course, is awareness about the final guidance on the topic from the FDA. The document has not yet unleashed a surge of new interest in ediary projects, she says. So some education around the value of collecting patient perspectives may be needed. "This is important and helps measure safety," she says of PRO. "We ourselves will help promote its importance."

Reflecting on her 25 years at Quintiles, Brown Stafford notes that back in the day, data from paper studies used to take six months to assemble. Now, with EDC, that process has been shortened to six weeks—and she can envision the process being further compressed to six days or even six hours. However slowly it was absorbed into the industry, technology is making the clinical trial process more expeditious. "It is all around integrating the data around the clinical core," she says.

At a higher level, Brown Stafford sees PRO data as an aid to enable expedited decisions to continue or kill promising life science research programs. Sponsors, she believes, "need integrated data in real time to move toward adaptive clinical trials. That data is important to have integrated and in a timely fashion. It provides a much more complete picture of the patient. By integrating the data as early as possible, we have these adaptive trials and sponsors can make decisions faster."

Editor's note: This article has invivodata's perspective on the Quintiles partnership.