Impact of clinical trials on the cost of cancer care

BACKGROUND. Empirical evidence on the economic impact of cancer clinical trials is in short supply, but it is widely assumed that clinical trials add at least 10% to overall costs. OBJECTIVES. To estimate how much, if at all, trial enrollment increases the use of scarce resources in treating breast, lung, lymphoma, and ovarian cancer patients. RESEARCH DESIGN. A profile of the cumulative charges for all inpatient and outpatient hospital care received by a sample of patients over an observation period beginning at diagnosis and continuing for upwards of 44 months postdiagnosis. Patients are classified by whether they were enrolled on an IRB-sanctioned research protocol and, if so, by the type of protocol. Both univariate and multivariate statistical tests are conducted to appraise whether cumulative charges differ between patients who were enrolled on key types of protocols and those who were not. SUBJECTS. Approximately 1,900 breast, lung, lymphoma, and ovarian cancer patients treated at a single center. MEASURES. Clinical endpoints and demographic, disease, and therapy characteristics of patients that drive treatment costs. RESULTS. Controlling for demographic and disease characteristics, initial therapy, and key endpoints, the net effect of trial participation on cumulative charges for hospital inpatient and outpatient care is never significantly positive at conventional confidence limits. This result is found for each of the four patient groups and three types of protocols encompassed by this analysis. CONCLUSIONS. Support for clinical trials by health care payers does not necessarily risk adding significantly to the cost of cancer care.