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

Kilgore ML, Goldman DP

University of Alabama at Birmingham, School of Public Health, 1665 University Blvd. RPHB 330, Birmingham, AL 35294-0022, United States.

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.

Published 10 December 2007 in Contemp Clin Trials, 29(1): 1-8.
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