The way Eli Lilly interprets it, investigator relationship management (IRM)—the recent trend among sponsors to cater to clinical sites in order to keep them around—involves figuring out who the best sites are, and giving them plenty of work.

Because sheer numbers of projects is what makes sites happy, says Jim Kremidas, the company’s director of global enrollment optimization.


“If an investigator has five patients, he’s going to make X amount, but if he gets 10 patients, he’s going to make a lot more,” Kremidas says. “They have costs they incur to try to get ready for a study—staffing, paperwork and the time associated with it. That’s not free, so the more patients they can bring into the study after that, the better for them.”

The main thrust of Eli Lilly’s IRM efforts, which the company is piloting this year and planning to roll out next year, involves paying close attention to which sites are most productive, then offering them more work.

Who Do We Like?

“Right now, we’re defining criteria on what constitutes a high-performance site,” Kremidas said. “We’re looking at enrollment figures—how well does a site do in getting patients and retaining them? With the good ones, we want to forge a deep relationship.”

Once the company has isolated the most productive locations, which Lilly plans to call “portfolio sites,” Kremidas says it will begin talking with each one not just about the next study in the pipeline, but other studies that may be months out, studies with which Lilly thinks the sites can excel—in essence, opening its portfolio to them, said Kremidas.

A Select Few

This constitutes a significant change for the company and the industry. “Historically, we approached sites on a study-by-study basis,” said Kremidas.

Soon, though, high-performing sites will be offered right of first refusal on a basket of upcoming studies. And then they will sign one terms and conditions contract for the lot of them, reducing much of paperwork and negotiating time. (Each study would have its own budgetary contract, though.) Kremidas said Lilly has begun sticking its toe in the water by discussing the concept with a few sites. But no multi-study contracts are in place yet.

Good for All

Of course, this isn’t just about happy times and money for the sites. “If we do it well, it could create efficiencies for us,” Kremidas said. “Twenty percent of sites never enroll a patient. If you’re working with sites that are good performers, there is less wasted time and money.”

Another upside for Lilly could be nudging out competitors with whom the high-performing sites also have relationships. Then, all the site’s energies would go toward Lilly’s drug development efforts and no one else’s.

“I worry about sites,” Kremidas said. “A typical site might have three trials going on with three sponsors, three different contracts. The logistics are outrageous. Now, the relationship will be symbiotic.”

Collaborative Spirit

Beth Harper, long-time site management consultant and president of Dallas-based Clinical Performance Partners, says Lilly’s approach is in line with what many competitors are planning. The goal is a less adversarial atmosphere.

“Between sponsors and sites, it’s been a very us-versus-them approach, with each focusing on who needs who more, when, really, we’re all after the same thing,” Harper said. “Sponsors now are really revisiting what their suppliers—the sites—do for them, and trying to enable them to be more successful. As in: what can we do to help you with enrollment? versus it’s your problem if you can’t recruit patients.”

Scientific Roles

Another move that could work out well for both Lilly and its sites is involving a few investigators on protocol design. “We think we can learn a lot from the physicans who are out there in practice, seeing patients, knowing what types of therapies patients are currently using,” said Kremidas.

This, he added, is contrasted with the in-house scientists who often work hard on a protocol that, in the end, proves impractical and can’t be carried out at sites, with patients. “The challenge is balancing what is going on in a real-live medical practice and trying to do science in a bubble. The doctors can help us with that.”

It will also help with some vexing logistical matters. “For some studies, we may ask patients to stay on site for three or four hours,” he said. “We will now let sites offer ideas on how to handle that.”

Fewer Contacts

Other investigator relationship management efforts Lilly plans to undertake include reducing the number of Lilly contacts with which a site must communicate. “Investigators are always telling us, ‘Hey, give me a single point of contact, someone who can run the traps for me within a big, bureaucratic organization and get things done,’ so we’re looking at that.”

What was the impetus for all this proposed change, besides looking around and seeing that competitors were doing many of the same things? It was Thomson CenterWatch’s recent site satisfaction survey, which came out in July. Lilly, which has ranked highly among sponsors in the past, didn’t do well so last time. “We didn’t even show up as a blip on the radar,” said Kremidas. “It was discouraging.”

Of course, like all drug makers now, Lilly wants to be the “sponsor of choice.” And Kremidas says he’s willing to do whatever it takes. “At the end of the day, the investigator is the person who interacts with the patient. Whatever we can do to make that go well, we will do it.”

by Suz Redfearn

Editor’s note: If you missed the other installments in our series this month, they were about” title=“Sanofi Aventis”>Sanofi Aventis and Wyeth.