This environmental scan, conducted by Mathematica and funded by ASPE, examines the types of direct and direct costs to patients associated with clinical trial participation. It also explores the effect of COVID-19 on costs to patients, including cost implications of clinical trial innovations widely implemented during COVID-19 and other efforts to increase diversity of clinical trials. The environmental scan concludes that there is limited research that quantifies direct or indirect costs to patients during clinical trials and no studies on the impact of the COVID-19 pandemic or clinical trial innovations on these costs. Among the available literature, travel costs and patient-reported financial toxicity are most often studied, and much of the literature focused on cancer clinical trials. There were also limited findings on what type of care is considered routine care by insurers during the course of a clinical trial and limited findings on the impacts of COVID-19 on this coverage or associated costs. However, there is evidence that routine care coverage policies did not address other insurance-related barriers to clinical trial participation like clinical trial sites being considered out-of-network. Finally, based on the literature reviewed, Black and Hispanic patients, patients over age 65, and rural patients are less likely to participate in clinical trials. Because differences in socioeconomic factors, like education level, income, and insurance type, may be an underlying cause of these disparities, addressing the cost of participating in clinical trials might have a downstream effect of improving clinical trial participation among these groups. Further information on estimates of direct and indirect costs to patients by clinical trial type (phase and disease) and on differences for underrepresented groups is needed, including among people with disabilities and older adults. Research to estimate the impact of certain clinical trial innovations like the shift to remote monitoring prompted by the COVID-19 pandemic on these costs could inform whether increased uptake of a decentralized trial approach could address financial and nonfinancial barriers to clinical trial participation.

Contents

• Acknowledgments
• Executive Summary
• I. Introduction
• II. Methods
  • A. Search strategy
  • B. Article review
• III. Findings
  • Topic 1: What are the types of direct and indirect costs to patients associated with clinical trial participation?
  • Topic 2: Coverage for “routine care costs” during clinical trials
  • Topic 3: Financial and nonfinancial barriers to clinical trial participation for underrepresented groups
  • Topic 4: Impact of COVID-19 and clinical trial innovations on costs to patients and barriers
• VI. Discussion and Conclusions
• References
• Appendix A. Complete Search Strategy

Suggested citation:

Calkins, K., E. Crabtree, E. Harrison, N. Williams, K. Barrett. “Impacts of COVID-19 on Clinical Trials Costs to Patients: Environmental Scan.” D.C.: Mathematica Policy Research, June 2024.

Disclaimer

This research was performed by Mathematica. The findings and conclusions of this research are those of the authors and do not necessarily represent the views of ASPE or the U.S. Department of Health and Human Services (HHS). Links and references to information from non-governmental organizations is provided for informational purposes and is not an HHS endorsement, recommendation, or preference for the non-governmental organizations