Affiliations of author: California Cancer Medical Center, Department of Medicine, University of Southern California, and Medical Oncology Association of Southern California, Los Angeles.
Correspondence to: Cary A. Presant, M.D., F.A.C.P., California Cancer Medical Center, 1250 S. Sunset Ave., Suite 303, West Covina, CA 91790-3961.
Two recent publications (13) provide important information regarding a major disincentive to clinical trial participationcost of care.
Mayo Clinic data.
Wagner et al. (1,2) identified a minimally increased cost of care for patients enrolled in cancer clinical trials among residents of Olmsted County, MN. A source of possible bias is increased intensity of care unrelated to the clinical trial as patients near the end of life, and the authors have made a creditable attempt to begin to study this variable in Table 5 of their article (1) and their erratum (2). Wagner et al. concluded that increased cost of care at the end of life was more common in cancer patients enrolled in clinical trials than in the control group.
This bias is likely because, in my experience, patients consenting to clinical trials seek the best possible outcomes and any hope possible. Such patients often seek all possible supportive measures and intensive treatment near the end of life, in contrast to nonparticipants in clinical trials who are often more accepting of hospice-type symptom care only.
To adjust for this possible bias, I recalculated the 1-year cost of care for clinical trial patients and control patients. I subtracted the care costs during the last 6 months of life for those patients who died during the first year of follow-up (Table 1).
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Kaiser Permanente data.
Fireman et al. (3) analyzed patients treated in clinical trials at Kaiser Permanente Hospitals compared with patients treated off clinical trials (3). However, because the authors at Kaiser Permanente compared a number of totally different types of therapy, it seemed instructive to contrast the costs of treatment on clinical trials with the costs of similar care "off trial" (Table 1). In my analysis, the actual costs of delivering chemotherapy on clinical trial were substantially less than the costs of delivering standard chemotherapy off trial (a cost saving for patients treated with experimental therapy of 13.1%).
Indeed, cost of care on clinical trials was more than costs of standard therapy off trial only when a new modality of therapy or supportive therapy was added to conventional treatment. Thus, addition of vaccine therapy in a circumstance where the standard of care was no therapy resulted in an increased trial cost of 27.0%; the investigational use of growth factor support in all patients to prevent leukopenia was 45.1% more than the routine use of chemotherapy without prophylactic growth factor support. The clinical trial high-dose chemotherapy plus bone marrow transplant (BMT) on a randomized basis cost 115.8% more than the treatment of similar patients with standard chemotherapy but without BMT. Finally, the addition of antiestrogens to radiation therapy cost 35.8% more than the standard treatment with radiotherapy alone.
Indeed, in the Kaiser Permanente experience, not only did the use of chemotherapy on a clinical trial within the Kaiser Permanente system cost less than the use of standard chemotherapy off trial, but also the cost of using BMT on a clinical trial ($54 396.00) was 32.6% less than the standard cost of caring for patients with the use of BMT off a clinical trial [$80 657.00, Table 3 in (3)]. This finding further substantiates the potential cost saving by treating patients on a clinical trial.
Lastly, the Kaiser Permanente data identified a 40% reduction in the mortality rate for patients on clinical trials. I calculated the incremental cost of care per year of life saved by treating patients on a clinical trial as $10 037.00 (Table 1). This cost is substantially less than the U.S. benchmark of $50 000.00 per year of life saved used to select therapies that can be utilized with acceptable cost/benefit ratio. This result suggests that the overall use of clinical trials in suitable consenting patients not only increased survival but also did so at an acceptable cost.
In conclusion, from these two studies, calculations indicate that the cost of care on a clinical chemotherapy trial is 4.7%13.1% less than the cost of standard chemotherapy. The addition of new modalities of therapy in a clinical trial often increases the cost of care but increases the length of life at an acceptable cost/benefit ratio. Physicians and insurers should encourage treatment of eligible, consenting patients on clinical trials.
REFERENCES
1
Wagner JL, Alberts SR, Sloan JA, Cha S, Killian J, O'Connell MJ, et al. Incremental costs of enrolling cancer patients in clinical trials: a population-based study. J Natl Cancer Inst 1999;91:84753.
2
Erratum: Incremental costs of enrolling cancer patients in clinical trials: a population-based study by Wagner et al. J Natl Cancer Inst 2000;92:1645.
3
Fireman BH, Fehrenbacher L, Gruskin EP, Ray GT. Cost of care for patients in cancer clinical trials. J Natl Cancer Inst 2000;92:13642.
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