Pfizer To Clinical Trial Sites: It’s Us Or Them

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decision.jpgIn what’s believed to be the first such move of its kind, Pfizer has been telling clinical trial sites that they must choose whether to do work for Pfizer or some other drugmaker - but they can’t handle trials for everyone at once. And given what Pfizer has to say about its experience, more drugmakers are sure to follow its lead - if they can still find good sites to commit to exclusivity.

Andy Lee, vp of clinical study and data management for Pfizer Global R&D, told the Drug Information Association (DIA) conference in Atlanta last week that once Pfizer began forcing high-performing sites to give up all other sites, data quality has improved, and recruitment for each site has skyrocketed, according to ClinPage. Pfizer’s research showed, by the way, that 80 percent of patients came from 26 percent of their clinical sites.

“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,” Lee told the crowd. “And now, what the sites are trying to do is manage discrepancies between sponsors rather than recruit patients.”

“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.” Nonetheless, “Building business units” out of specific sites has worked, he says. The drugmaker scrutinized a trial it conducted after demanding exclusivity from clinical sites, and noted that 63 of the sites involved recruited more than 50 subjects, while 30 of the sites recruited more than 100, and one site brought in more than 725 subjects.

Hat tips to ClinPage, Pharma’s Cutting Edge, PharmaGossip

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  1. [...] PharmaLot is a post on the new proposal by Pfizer Inc to demand that any site that performs clinical trials sponsored by [...]

  2. I just corresponded with Andy Lee. I offhandedly mentioned the DIA report, and he wrote back that reports about an exclusive arrangement setup are completely inaccurate. He said, “Pfizer does not practice ‘exclusive’ contracting, nor is it a strategy for the future. We have never done this and we do not force sites to work with us.” In a second exchange, he added, “It is not a viable or sustainable strategy, we know that and so do the sites.”

    –Gil Roth
    Editor
    Contract Pharma

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