§An objective of the
two trials in patients with leukemia is
to assess efficacy and safety of high dose methotrexate (HD MTX) vs Capizzi (C) MTX.Both studies seek to evaluate and answer questions about several potentially important drugs or regimens in pediatric leukemia.
discuss whether the study designs will enable isolation and comparison of the effects of HD MTX versus C MTX,
and identify specific
aspects of the designs most critical in delineating the effects of HD MTX.
discuss which of the study outcomes are most relevant to assessing HD MTX efficacy and toxicity
comment on the adequacy and frequency of the safety assessments to assess toxicity, particularly