Incremental costs of enrolling cancer patients in clinical trials: a population-based study

Background: Payment for care provided as part of clinical research has beco me less predictable as a result of managed care. Because little is known at present about how entry into cancer trials affects the cost of care for ca ncer patients, we conducted a matched case-control comparison of the increm ental medical costs attributable to participation in cancer treatment trial s. Methods: Case patients were residents of Olmsted County, MN, who entered phase II or phase III cancer treatment trials at the Mayo Clinic from 1988 through 1994, Control patients were patients who did not enter trials but who were eligible on the basis of tumor registry matching and medical recor d review. Sixty-one matched pairs mere followed for up to 5 years after the date of trial entry for case patients or from an equivalent date for contr ol patients. Hospital, physician, and ancillary service costs were estimate d from a population-based cost database developed at the Mayo Clinic. Resul ts: Trial enrollees incurred modestly (no more than 10%) higher costs over various follow-up periods, The mean cumulative 5-year cost in 1995 inflatio n-adjusted U.S. dollars among trial enrollees after adjustment for censorin g was $46424 compared with $44133 for control patients. After 1 gear, trial enrollee costs were $24645 compared with $23964 for control patients. Conc lusions: This study suggests that cancer chemotherapy trials may not imply budget-breaking costs. Cancer itself is a high-cost illness. Clinical proto cols may add relatively little to that cost.