Abstract
Objective: Clinical trials are an essential element in the improvement of cancer prevention and treatment strategies. A widely held perception is that costs of care for clinical trial (CT) patients are higher than standard of care (SOC). There is a paucity of data supporting this assertion. The objective of this study was to determine the costs of breast cancer patients enrolled on a clinical trial compared to eligible patients who did not participate in a trial. Methods: A retrospective cohort study was conducted to compare costs incurred by 97 breast cancer patients participating in a mix of industry and non-industry sponsored clinical trials with those costs incurred by 97 eligible nonparticipants who received SOC. Resource utilization was tracked for one year and quantified to standardized price templates. Seven cost variables were examined: physician time, nursing time, tests and procedures, diagnostic imaging, pathology, radiation therapy, and pharmaceuticals. Results: Mean costs were marginally higher for the CT patients than the SOC patients for all seven cost variables, as were the mean total costs ($16,418 versus 10,002, p-value=0.046). Pharmacy costs constituted the largest difference between the trial and SOC patients (mean difference=$5,157, p=0.08). After excluding all drugs that were provided by the study sponsors at no charge, the remaining average pharmacy costs were more equal between groups (mean difference=$990, p=0.45). As a result, the mean difference between the total costs of the two groups was reduced by two-thirds, from $6,396 to $,227 and statistical significance was lost (p=0.14). Conclusions: This study revealed only minor differences in the cost distribution of patients enrolled in CT versus those receiving SOC. This is similar to results previously seen for prostate cancer patients.
Highlights
Breast cancer continues to be the most common cancer diagnosis in Canadian women, with more than 2,000 new cases and 5,000 cancer deaths recorded annually [1]
Mean costs were marginally higher for the clinical trials (CT) patients than the standard of care (SOC) patients for all seven cost variables, as were the mean total costs ($16,418 versus 10,002, p-value=0.046)
This study revealed only minor differences in the cost distribution of patients enrolled in CT versus those receiving SOC
Summary
Breast cancer continues to be the most common cancer diagnosis in Canadian women, with more than 2,000 new cases and 5,000 cancer deaths recorded annually [1]. A widely held perception that costs of care for trial patients are higher than standard of care continues to be a barrier to research in many cancer centres [7,8]. The conduct of cancer clinical trials is hampered at least in part by a commonly held view that patients enrolled in clinical trials consume significantly more health-care resources than patients receiving standard of care [4,8]. This perception is especially relevant in Canada, where a single payer health care system operates under constant pressure to eliminate “non-essential” activities [12,13]. A thorough understanding of any added costs or demands of having a patient enrolled in a trial, or cost savings as a result of patients participating in research, would be beneficial for researchers and administrators to inform decision
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