Editor’s note:  This story has been revised since it was posted on June 29, 2007.

As it explained at DIA, however, Pfizer is guiding more sites and investigators to either recruit patients for its trials or make other scientific contributions. Just not both. The company says this strategy is hardly unique or proprietary, and that it will ultimately reduce the number of sites that decide not to work for industry at all.  We’ve also posted an editorial clarification that has new comments from the company.

We all know sponsors have a devil of a time finding and keeping strong clinical sites. Every firm in the industry worries about that.

But Pfizer is actively exploring how to work with sites that find negligible and large numbers of patients. The crux of the matter is that both site and patient recruitment remain thorny, industry-wide issues.

Maximizing Site Retention

The real question is how the industry should adjust site recruitment given oft-discussed trends that will require the industry to find more sites and patients at a time when both are in scarce supply.

For its part, Pfizer says it is trying to understand the business model for clinical sites. That inquiry appears to be unfolding in discussions with each prospective site. The goal: to gauge the needs of sites, partner with them in customized ways, and (with luck) ensure that they stay involved in research (for Pfizer and other companies). That should be in the mutual economic and scientific interest of sites, sponsors and society.

Wasted Energy

As many observers of the industry know, many sites today juggle multiple sponsors to attempt to make a profit. Even then, it’s not clear that running clinical trials is an economically rewarding activity for some sites, which often leave the industry after one or two studies.

As Andrew Lee, vice president of clinical study and data management for Pfizer Global R&D, told the Drug Information Association (DIA) conference in Atlanta, Pfizer has rediscovered the 80/20 rule. A small group of sites can find most of the patients. Pfizer’s research showed that 80 percent of patients came from 26 percent of their clinical sites.

Pfizer says it has taken a hard look at the output from its clinical sites. Many recruited so few patients that it was surprisingly expensive to send in drug supplies and human monitors. From the site perspective, the investigator and staff may have been too consumed by patient care to understand key business concepts. If a site consistently fails to recruit enough patients to attain its break-even point, for example, it will not be financially able to work on trials for any company in the industry.

Techno-Overload

Lee told the packed DIA session that Pfizer has looked closely at how its sites were working. The company noticed that many sites were spending lots of time and energy juggling the complicated tools of multiple studies. The way Lee and his team figured it, that was hurting both Pfizer and the sites themselves.

“If you do 10 studies, you’re working with 10 different sponsors, 10 different IVRS systems, 10 different data capture systems, 10 investigator meetings, 10 different standards,” said Lee. “And now, what the sites are trying to do is manage discrepancies between sponsors rather than recruit patients.”

New Stipulation

Here’s where it gets interesting. The company has made it clear that sites working for other sponsors could still have a relationship with the company—but not enlist patients.

Said Lee: “We went back to some of our top [sites] who said, ‘We’re doing so and so’s study and sponsor X’s study,’ and we said, ‘Well, good luck, but either you do theirs or you do ours.’ They said, ‘You’ve got to be crazy. Don’t you want to work with us?’ We said, ‘We’d love to work with you, but we want to see an economically viable model. So you’re in or you’re out. It’s black or it’s white. We’ll still use you. You can still help us on the advisory committees, you can be on the DSMB [data safety monitoring board] etc., but you’ve either got to commit to sponsor A or sponsor B. We don’t mind [which]—take your pick. Because this is neither good for them nor us.’ ” Lee says this resulted in Pfizer “turning its back on a lot of really good people, not in terms of our relationship, but in terms of the trial conduct.”

Site Stratification

Thus Pfizer wants to maintain scientific and intellectual ties to sites, leaning on them to work on advisory committees, publications and safety boards. But not all sites will be asked to recruit patients if that may not be in a site’s interest or, of course, right for Pfizer, given the costs or scientific concerns of having small numbers patients recruited by a site.

“Building business units” out of specific sites has worked for Pfizer, Lee said. More focussed sites are recruiting better. The company scrutinized one trial it conducted, and noted that 63 of the sites involved in that study recruited more than 50 subjects, while 30 of the sites recruited more than 100. One site brought in more a staggering 725 subjects.

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