Audio
TRANSCRIPT: Louise B. Grochow, M.D., chief of the Investigational Drug Branch, National Cancer Institute speaks at the March 11, 2002, Science Writers Seminar on Molecular Targets in Cancer Therapy:
Issues regarding expertise, cost, and dose-finding in molecular targeting trials (Part 1)
What we need to put together in terms of extras to do that kind of a clinical trial, used to be that the trial design was done on handout from Dr. Sausville's group who got it through clinical screening, toxicology and medical oncologists. But to do these new kinds of trials with new endpoints, we're going to need translational experts who can participate in the trial design. We're going to need people who know what that the research x-rays are, or who understand what the biopsies results are, and who can interpret that during the course of the trial and say, "Hm, maybe we're doing that biopsy too soon. Maybe the next batch of patients we need to biopsy at the end of the third week."
In terms of the kinds of experts in addition to the good old medical oncologists, and an analytic chemist, who can do pharmacokinetics -- basically just measuring drug in the blood to see if the amount in human being's blood is similar to what it took in a mouse to get some kind of useful effect -- we're going to need those same people, but now with specialized research pathologists, specialized imagers, specialized radiologists who are used to doing especially safe biopsies. And in terms of endpoint, like I said before, it was based on toxicity and how much drug was in the blood using a plasma assay. But now you're going to be doing that, plus whatever the molecular target is. Plus it's probably going to double, for doing single-patient in Phase I trials, and that's roughly the cost at the site.
Different companies double to deal with their internal manpower in dealing with the trial. |