Re: Pfizer clarification and IVUS notes
>If Pfizer randomizes by surgeon/cardiologist (as in ZymoGenetics' rhThrombin pivotal trial), then the point is probably moot. If they have some sort of centralized IVUS center where a limited number of cardiologists perform the IVUS (akin to centralized radiography adjudication in oncology trials), then it also might be a moot point… Any IVUS-based approach that does not use one of the first two approaches should be looked at with at least as much skepticism as investigator determinations of objective responses in oncology trials.<
It’s a virtual certainty that PFE’s Torcetrapib trials will adopt one or both of the anti-biasing methods you describe. Hence, your warning in regard to the unreliability of the IVUS readings strikes me as a red herring. Regards, Dew
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