Drug costs and out-of-pocket spending in cancer clinical trials.

OBJECTIVE To estimate the effect of clinical trial participation on drug utilization, drug costs, and out-of-pocket expenditures for cancer patients. METHODS The study used a national probability sample of patients participating in cancer clinical trials and a matched cohort of patients not enrolled in trials but receiving treatment for the same cancers from the same providers. Subjects were interviewed about prescription drug utilization and out-of-pocket drug expenditures. We estimated treatment costs based on a large pharmacy transaction database. Multivariate regression was used to estimate the effects of trial participation on drug costs and out-of-pocket expenditures. RESULTS Participants in clinical trials incurred higher prescription drug costs than non-participants: an average of $131 over a six-month period. However, there was no significant difference in out-of-pocket expenditures for the two groups. CONCLUSIONS Participation in clinical trials was associated with a modest increase in prescription drug utilization and costs, but these costs did not necessarily impose an economic burden on cancer trial participants.