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Size matters in blood substitute trials
Monday, August 17, 1998
Mortality concerns that led to the halting of a Phase III blood
substitute trial by Baxter Healthcare Corp. in March now may be prompting the FDA to push
blood substitute companies to collect more robust safety data. The agency has asked
Northfield Laboratories Inc. (NFLD) to expand an ongoing Phase III trial of its PolyHeme
hemoglobin-based product from 240 patients to 600, and it appears that other companies are
being asked to do the same.
While the FDA doesn't comment on ongoing studies, NFLD said the agency
expressed concerns based on safety issues raised in other trials. NFLD Chairman and CEO
Richard DeWoskin suggested the HemAssist data were likely the basis of the FDA's concern.
DeWoskin said the agency told him the request to enlarge trials will be across the board
to blood substitute manufacturers. He did not know whether the agency is limiting its
concerns to hemoglobin-based products.
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