After a complaint from Pfizer, we’ve updated a recent story about DIA. There’s a link to our first story at the bottom of this article. It’s clear ClinPage accurately quoted Andy Lee, Pfizer’s vice president of clinical study and data management. He and the company do have concerns about sites working for too many sponsors, using too many technologies.

But we incorrectly extrapolated a key assertion from Lee’s remarks. Pfizer never requests that clinical trial sites work exclusively for the company. For a host of practical, ethical and scientific reasons, the company has never asked any site to choose between working for Pfizer and another sponsor, Lee told us. ClinPage was wrong about that. We apologize to Lee and Pfizer.

Our Favorite Pie Is Crow

After Pfizer agreed to elaborate on what it said at DIA, we were able to hear a bit more about its philosophy. (We had tried to have a similar conversation in late June.)

The bottom line: Pfizer is stratifying its relationships with sites in a more granular and predictive way. In some circumstances, sites and Pfizer may jointly agree that recruitment is an appropriate responsibility for a particular study—or that a site’s ancillary clinical expertise may be more valuable to Pfizer. So the choice isn’t between Pfizer and another sponsor, as we originally reported. For some trials and sites, the choice is between recruiting and playing other scientific roles.

Familiar industry trends are driving the shift. More patients are needed in rising numbers of trials. For years, investigators have participated in one or two studies and left the industry. Nothing new there.

Tiers of Performance

Such factors have lead Pfizer to rethink its arrangements with sites. As Lee made clear at DIA, Pfizer’s been thinking about the business model of the clinical site. It has to, for the sake of its productivity and the industry’s.

One of the brutal realities here is that it is not always profitable for investigative sites to work for the industry. Especially for sites just learning the ropes, it may only belatedly be clear if a specific trial was economically worthwhile—much less a tolerable burden of paperwork and regulation.

‘What We Wanted To Avoid’

Rather than put an investigator into a position where he or she would elect to leave industry-sponsored research, Pfizer is trying to work with non-recruiting sites to let them assist in other ways. That might include helping with advisory committees, scientific publications or serving on data safety monitoring boards (DSMB). What seems new is that Pfizer is less interested in allowing low-recruiting sites to absorb resources that might be better spent on high-recruiting sites.

“The point is that good investigators or good academics can have a relationship with a sponsor that is independent of recruitment,” Lee told ClinPage after DIA. “There are many ways they can contribute to a study without putting on one or two patients. That’s what we wanted to avoid.”

Tailoring Each Relationship

Forging strong relationships with sites of all kinds is a Pfizer priority. Says Lee: “Each site has a different set of needs. That’s part of the relationship. It isn’t one size fits all.” Some sites need resources. Some need equipment. Some need time.

Part of the reason for carefully choosing which sites will recruit, Lee said, is biostatistical. “It’s not helpful from a statistical point of view to have small numbers,” Lee says. And some of the reasons are logistical: the cost of sending drug supplies and human monitors to sites around the globe.

Win-Win

The phrase Lee repeated often was “win-win.” It’s in both Pfizer’s and sites’ interests to make sure the business model of each site is viable. “We try to find win-win ways to help sites enhance their recruitment,” Lee says.

Perennial challenges to recruiting patients and sites are intensifying, Lee notes. As he noted in our original story, a fraction of high-performing sites tend to find a disproportionately large share of patients.

New Realism?

Pfizer is keeping an open door to low-recruiting sites, just not kidding itself they will enroll 50 patients if 2-3 subjects is more realistic. “There are times when we have not engaged someone for [recruiting] clinical patients,” Lee says. But the door is not shut: “It’s OK to engage these people as long as the expectations are there up front.”

Lee doesn’t think Pfizer’s strategy is unique. In some cases, he says, “sponsors and investigative sites realize that there is either insufficient resource at the site, or an inadequate patient pool to meet the needs of multiple trials of a similar nature. In these instances, it may be better if fewer protocols are conducted at the site in order to meet the scientific, investigative site and sponsor needs rather than taking on all available competing protocols at the risk of diluting the investigative sites’ capabilities. While this may be disappointing for either the sponsor or the investigative site in the short term, it is better for the overall goals of clinical research and the likelihood of repeat work in the future.” Hard to disagree with that.

Technology Aspects

On the technology front, the company is rolling out what sounds like a customized integration of electronic data capture, clinical trial management (CTM) and customer relationship management (CRM) systems. Pfizer calls this its “Clinical Trial and Relationship Management.” The company is combining software from Oracle (and its Siebel Clinical acquisition), Perceptive Informatics (Impact), ClinPhone (TrialWorks) and Winchester Business Systems (Protocol Manager).

Such tools could help it pay sites more promptly. Lee was candid on that front, saying the company is working on scaling the investigator payment systems. “We can get it right for isolated studies,” he says. “But we can’t get it right across the company. Other sponsors have a similar problem.” Indeed, the integration of electronic data capture (EDC) and clinical trial management (CTM) systems could make sites happier. Lee’s sense is that most companies in the industry are working on their own combinations of EDC and CTM systems.

Pfizer is also using technology to make the training of site staff and physicians as brief as possible. While there’s no doubt face-to-face meetings are invaluable for protocol-specific issues, some good clinical practice training GCP may be transitioned to a DVD by 2008, with a quiz to establish that the information has been absorbed. Some investigators are quite well-steeped in GCP, Lee notes. For such individuals, there may be more effective ways to use the time at training meetings.

Here, for future reference, is our revised story on what Lee said at DIA.

—by .(JavaScript must be enabled to view this email address)