Jornal de Ensaios Clínicos
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A Comparison of Incremental Costs of Breast Cancer Clinical Trials to Standard of Care

Britney Jones, Misha Eliasziw, Bernhard J Eigl and Rachel Syme

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.