| Abstract
| - BACKGROUND: Payment for care provided as part of clinical research has become lesspredictable as a result of managed care. Because little is known at present about how entry intocancer trials affects the cost of care for cancer patients, we conducted a matched case-controlcomparison of the incremental medical costs attributable to participation in cancer treatmenttrials. METHODS: Case patients were residents of Olmsted County, MN, who enteredphase II or phase III cancer treatment trials at the Mayo Clinic from 1988 through 1994. Controlpatients were patients who did not enter trials but who were eligible on the basis of tumorregistry matching and medical record review. Sixty-one matched pairs were followed for up to 5years after the date of trial entry for case patients or from an equivalent date for control patients.Hospital, physician, and ancillary service costs were estimated from a population-based costdatabase developed at the Mayo Clinic. RESULTS: Trial enrollees incurred modestly (nomore than 10%) higher costs over various follow-up periods. The mean cumulative 5-yearcost in 1995 inflation-adjusted U.S. dollars among trial enrollees after adjustment for censoringwas $46 424 compared with $44 133 for control patients. After 1 year, trialenrollee costs were $24 645 compared with $23 964 for control patients.CONCLUSIONS: This study suggests that cancer chemotherapy trials may not implybudget-breaking costs. Cancer itself is a high-cost illness. Clinical protocols may add relativelylittle to that cost.
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