5 Drivers Of Patient Financial Toxicity — And 10 Tips To Address Them

By Tina Bowdish, senior director, clinical research administration, Vanderbilt-Ingram Cancer Center

Patient financial toxicity refers to the financial burden and hardship experienced by patients participating in clinical research studies. This concept has gained pharmaceutical company attention due to its potential impact on patient enrollment and retention, as well as the generalizability of results. It can also deter eligible patients from participating in clinical trials or, if they do enroll, lead to premature withdrawal. Not only does this harm individual health, but it can also affect the generalizability and completion of clinical research.

What Contributes To Patient Financial Toxicity?

Here are six key drivers:

1. Costs To Participate

Clinical trials involve various costs for participants, including but not limited to expenses related to travel to trial sites, housing or hotel accommodations, meals, childcare, and parking. Even though the trial sponsor may reimburse some costs or offer a stipend, typically, not all expenses are covered.

2. Insurance Coverage

Participation in a clinical trial can sometimes affect insurance coverage, leading to higher out-of-pocket costs for participants. This can include denial of coverage of any care related to the clinical trial, co-pays, deductibles, co-insurance, and other healthcare expenses not covered by the trial.

3. Loss Of Income

Patients may face income loss if they need to take time off from work for more frequent trial visits or if they experience treatment-related side effects that impact their ability to work. Caregivers may also experience income loss if they are accompanying a loved one to a trial visit.

4. Financial Planning

The unpredictability of healthcare costs, especially when participating in a clinical trial, can create financial planning challenges for patients and their families. This uncertainty adds to the stress and burden of participating in the trial. While informed consent documents explain the research and the risks, they do not have specific dollar amounts for the items considered standard of care. Researchers need help counseling participants as each payor has a contract with the organization and there is a lot of variability.

5. Unethical Provider Practices

Ethically, researchers, and sponsors have a responsibility to minimize the financial burden on participants. This includes communicating transparently about costs and providing financial assistance or reimbursement where possible. If they do not, then patients can be unduly burdened financially.

How To Prevent Patient Financial Toxicity

Preventing patient financial toxicity in clinical trials involves implementing strategies that reduce the financial burden on participants and ensure their financial well-being is considered throughout the trial process.

Here are 10 approaches that can help:

1. Communicate clearly.

Provide clear and comprehensive information to potential participants about the costs associated with the trial at the same time the trial is presented. This includes explaining what expenses will be covered by the trial sponsor, what expenses may need to be paid out-of-pocket, and any potential impact on insurance coverage.

2. Offer financial counseling.

Offer financial counseling services to participants to help them understand the financial implications of participating in a trial. Counselors can assist in budgeting, navigating insurance issues, and identifying sources of financial assistance. Ensuring these financial counselors have the appropriate training to include coverage of Medicare-qualifying clinical trials is imperative to compliance with the regulations and a smoother process for the participant.

3. Ensure coverage for the cost of participation.

Ensure that essential costs — travel expenses, lodging, meals, and other incidental costs — incurred by participants are covered by the trial sponsor.

4. Establish clear reimbursement policies.

Establish clear policies for reimbursing participants for out-of-pocket expenses. Make the reimbursement process straightforward and timely to minimize financial strain on participants. This can be accomplished by providing receipts to the study team and the reimbursement funds being loaded onto a reloadable debit card or electronic funds transfer (EFT) to an account within two business days.

5. Understand the impacts on insurance coverage.

Work with patients to understand how their participation in the trial affects their insurance coverage. Provide guidance on the potential impacts and advocate for policies that protect participants from increased out-of-pocket expenses. (See “Become an advocate” below.)

6. Seek out financial assistance programs.

Develop or participate in programs that provide financial assistance to participants who may face financial hardship due to their involvement in the trial. This could include philanthropic funds, grants, subsidies, or access to patient assistance programs. Example programs include the American Cancer Society and Ronald McDonald House. Connect with the social workers in your specialty for more ideas.

7. Streamline protocol design.

Consider financial factors when designing clinical trial protocols. Whenever feasible, minimize the number and frequency of visits that require extensive travel or time away from work. It is important to realize even short trips can result in a cumulative effect on missed work. Many employees cannot just take an hour off work and instead must miss an entire shift.

8. Conduct an ethical review.

Include an assessment of financial considerations in the ethical review process of clinical trials. Ensure that the trial design considers the potential financial impact on participants and incorporates measures to mitigate these effects. Patient advocacy groups can play a role in addressing these concerns. You can find many of these groups online for your specialty or you can create one at your own organization.

9. Become an advocate.

Advocate for policies and guidelines at institutional, national, and international levels that promote equitable access to clinical trials and address financial barriers for participants. Many industry sponsors are lobbying state and local governments, and participant assistance must be included. Larger research institutes and academic medical centers also have pathways for improvement initiatives.

10. Adopt a patient-centered approach.

Adopt a patient-centered approach throughout the trial process. Solicit feedback from participants regarding financial concerns and adjust trial procedures accordingly to better support their needs.

Final Recommendations For Reducing Patient Financial Toxicity

By implementing these strategies, researchers, sponsors, and healthcare providers can help minimize the financial burden on participants in clinical trials, thereby enhancing participant recruitment, retention, and overall trial success while promoting ethical standards in clinical research.

Overall, managing patient financial toxicity in clinical trials requires a multifaceted approach involving stakeholders such as researchers, sponsors, healthcare providers, and patient advocacy groups. Recognizing and mitigating these financial challenges can help ensure equitable access to clinical trials and improve the overall experience for participants.

About The Author:

Tina Bowdish is an accomplished and performance-driven healthcare leader with 25+ years of progressive leadership roles and expertise in various clinical research positions with a patient-centric focus. Tina has experience conducting Phase 1-4 clinical trials, including laboratory processing, clinical operations, budgeting, quality control, and compliance for human subject research with a focus on oncology. Tina has a well-rounded background and a deep understanding of the different pillars among clinical trial teams, including clinical operations, regulatory, and finance.