Cost of care for patients in cancer clinical trials.

BACKGROUND Information on the costs of medical care for patients enrolled in clinical trials is needed by policymakers evaluating ways to facilitate clinical research in a managed care environment. We examined the direct costs of medical care for patients enrolled in cancer clinical trials at a large health maintenance organization (HMO). METHODS Costs for 135 patients who entered 22 cancer clinical trials (including 12 breast cancer trials) at Kaiser Permanente in Northern California, from 1994 through 1996 were compared with costs for 135 matched control subjects who were not enrolled in such trials. Cancer registry data and medical charts were used in matching the control subjects to the trial enrollees with respect to cancer site, stage, date of diagnosis, age, sex, and trial eligibility. The direct costs of medical care were compared between trial enrollees and the control subjects for a 1-year period, with data on costs and utilization of services obtained from Kaiser Permanente databases and medical charts. RESULTS Mean 1-year costs for the enrollees in trials were 10% higher than those for the control subjects ($17 003 per enrollee compared with $15 516 per control subject; two-sided P =.011). The primary component of this difference was a $1376 difference in chemotherapy costs ($4815 per trial enrollee versus $3439 per control subject; two-sided P<.001). Costs for the 11 enrollees in trials that had a bone marrow transplant (BMT) arm were approximately double the costs for their matched control subjects (borderline significance: two-sided P=.054). The $15 041 mean cost for the enrollees in trials without BMT was similar to the $15 186 mean cost for their matched control subjects. CONCLUSIONS Participation in cancer clinical trials at a large HMO did not result in substantial increases in the direct costs of medical care.

[1]  A. Dobson,et al.  The impact of managed care on clinical research: a preliminary investigation. , 1996, Health affairs.

[2]  R. Deyo,et al.  Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. , 1992, Journal of clinical epidemiology.

[3]  C. Somkin,et al.  Cost of Care for Cancer in a Health Maintenance Organization , 1997, Health care financing review.

[4]  Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a Population-Based Study. , 2000, Journal of the National Cancer Institute.

[5]  J. Selby,et al.  Linking Automated Databases for Research in Managed Care Settings , 1997, Annals of Internal Medicine.

[6]  Evaluating cancer costs in NCI trials. , 1998, Cancer treatment and research.

[7]  M. Brown Cancer patient care in clinical trials sponsored by the National Cancer Institute: what does it cost? , 1999, Journal of the National Cancer Institute.

[8]  N. Krieger Overcoming the absence of socioeconomic data in medical records: validation and application of a census-based methodology. , 1992, American journal of public health.

[9]  M. Mcgrath Cost Effectiveness in Health and Medicine. , 1998 .

[10]  C. Mackenzie,et al.  A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. , 1987, Journal of chronic diseases.

[11]  W. Barlow,et al.  Breast cancer survival and treatment in health maintenance organization and fee-for-service settings. , 1997, Journal of the National Cancer Institute.