Clinical Trials, Disparities, and Financial Burden: It’s Time to Intervene

Abstract

The additional financial burden of clinical trial participation and the lack of availability of trials at safety net facilities make it essentially impossible for underserved patients to participate. If allowed to continue, these trends will ensure that only affluent cancer patients will be able to participate in clinical trials. Interventions to better handle financial stresses and widespread policy change are necessary to optimize high-quality care for all patients with cancer.

An overarching goal of the entire oncology community is to ensure access to the best-quality care for all patients with cancer, regardless of race and socioeconomic status. The best possible treatment option for many patients with cancer is participation in a clinical trial. Although clinical trials offer the most novel and promising therapies, minority participation in trials is abysmally low for many reasons. As cancer clinical trials become more complex in the current era of targeted therapy and immunotherapy, trial complexities threaten to further reduce access to these trials for cancer patients in underserved populations.

This issue of The Oncologist addresses the important issues of clinical trials: cancer disparities and financial burden. Gerber et al. analyzed cancer clinical trials activated at an academic medical center and its satellite safety net site [1]. Their study revealed that, over time, a decreasing proportion of cancer clinical trials were available at the safety net site, thereby decreasing access to this underserved group. Primary reasons for this trend included increased clinical trial complexity and costs to the institution. Also in this issue, Nipp et al. describe the mounting evidence of financial burden experienced by cancer patients receiving standard treatments and the additional financial burden of clinical trial participation [2]. They document the heavy additional burden imposed by more frequent travel, the need for overnight accommodations, and the loss of work time imposed by clinical trial participation. These papers rightly call for effective interventions to ease the financial strain imposed by clinical trial participation.

In the general cancer population, people with cancer are more than 2.5 times more likely to declare bankruptcy than people without cancer [3]. Cancer patients who file for bankruptcy are more likely to be younger, women, and not white. If these bankruptcy rates exist in the general cancer population, the additional financial burden of clinical trial participation and the lack of availability of trials at safety net facilities make it essentially impossible for underserved patients to participate.

If allowed to continue, these trends will ensure that only affluent cancer patients will be able to participate in clinical trials. This will lead to the inability to generalize results to a general cancer population. More important, from a social justice perspective, cancer patients from minority and low-socioeconomic status populations will be denied access to some of the most promising therapies. Whether one can participate in a promising clinical trial should not be decided by the size of one’s wallet. The cost of complex clinical trial participation should not be placed on the shoulders of weary and financially strapped patients. Interventions to better handle these financial stresses and widespread policy change among important stakeholders, such as payors and industry sponsors, are necessary to optimize high-quality care for all patients with cancer.

Disclosures

The author indicated no financial relationships.