Fine tuning brings its own risks The FDA's decisions to halt and restart - all within one week - ProCyte Corp.'s Phase III trials of its Iamin peptide-copper compound to treat diabetic foot ulcers illustrates one of the tradeoffs in pivotal trial design - generating greater statistical significance can mean moving into sicker patients who are more likely to die or experience adverse events.
PRCY's original decision to do the Phase III studies in patients with larger ulcers (>100 mm
2) was dictated by statistical considerations. "The drug worked equally well in all