Objectives: We investigated the impact of clinical trial participation on Medicare costs in a large community-based practice.

Study Design: Retrospective matched cohort

Methods: We created matched comparator groups for OCM episodes initiated between 2016-2018 based on cancer type, metastatic status, comorbidity number, performance status, and age using linked EMR and Medicare OCM claims data. The significance of differences in total cost between trial and non-trial episodes was assessed using the Mann–Whitney U test. We assessed impact on active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations.

Results: During the study period, 8,053 completed OCM episodes met study criteria; 459 episodes included clinical trials. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes, independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08). Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p<0.01).

Conclusion: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in community-based clinical trials does not increase total cost of care nor enhance financial exposure to payers.