Clinical Trials and Their Financial Barriers: Increasing Participation, Lowering Financial Toxicity

Jan 07, 2019

By Carson Rolleri, ASCO Communications

Clinical trials, a vital aspect of cancer research, can result in new, effective treatments that can help people with cancer live longer, healthier lives. So why is the participation so low?

According to a variety of studies, there’s not just one reason. Narrow eligibility criteria, demanding testing and time commitments, and barriers at the organizational, personal, and educational level for clinicians and patients alike all contribute to this “why.” Another reason? The often steep financial toxicity that comes with participating in a clinical trial.1

Financial toxicity, or the negative effects that paying for cancer care can have on patients and their families, is a large factor preventing eligible patients from enrolling or continuing on a clinical trial.

“Clinical trials are essential for evaluating the safety and efficacy of new cancer treatments, but cancer researchers have seen consistently low patient participation levels—especially among underserved patient populations—in part due to the financial burdens facing many patients with cancer,” said 2018-2019 ASCO President Monica M. Bertagnolli, MD, FACS, FASCO.

In fact, the effects of financial toxicity can be found throughout the different types of costs in the cancer care continuum, including direct medical costs (medication, appointments, imaging, etc.), direct nonmedical or ancillary costs (transportation, childcare, caregiving, etc.) and indirect costs (less time at work resulting in lower or lost wages, etc.). Between 20% to 40% of adult patients with cancer report some combination of financial hardship, regardless of whether they are enrolled in a clinical trial.2,3

“A cancer diagnosis in and of itself results in financial toxicity,” said Karen M. Winkfield, MD, PhD, co-chair of the ASCO Roundtable on Addressing Financial Barriers to Clinical Trials. “Enrollment in clinical trials may add to these ancillary expenses if more frequent monitoring is required to assess efficacy or ensure patient safety while on study. Although the financial toxicity of cancer care is being discussed, integral costs above ‘standard care’ that clinical trial participants are exposed to may create a barrier that prevents some from enrolling.”

When patients are able to participate in a clinical trial regardless of their background and financial means, existing disparity gaps for disease outcomes can narrow. In data obtained through a recent SWOG clinical trial, rural and urban patients with equal access to cancer care had similar outcomes. Previously, rural patients had experienced worse survival rates than their urban counterparts. The data suggest that improving access to uniform treatment strategies for all patients with cancer may help resolve the disparity in cancer outcomes.4

Increasing access to clinical trials for patients of every background by decreasing financial toxicity not only ensures every person who is eligible and wants to enroll can, but it can also make the results of the trial more relevant to a larger population outside of the study. 

“Addressing financial barriers will help improve the enrollment rate and the efficiency, quality, and applicability of cancer research,” said Dr. Bertagnolli. “By including more—and more diverse—participants in our research studies, we expand our ability to care for all patients.”

Recognizing the importance of increasing clinical trial participation, and the negative effects that financial toxicity can have on patients and their families, the ASCO Health Equity Committee convened a roundtable discussion in 2017 to better define the scope of financial burdens on clinical trials and identify solutions both at the policy and clinical level.

“Among ASCO’s most important priorities are to promote cancer research and to ensure access to quality care for all people with cancer,” said Beverly Moy, MD, MPH, FASCO, co-chair of the ASCO Roundtable on Addressing Financial Barriers to Clinical Trials. “Historically, ASCO has been a leader in protecting underserved patients with cancer, issuing policy statements to address cancer disparities through strategic efforts following the Affordable Care Act and advocating for Medicaid reform. This multi-stakeholder roundtable was created to address the important issue of financial barriers to cancer clinical trial participation, catalyzing meaningful policy changes that ensure all patients have access to these important treatment options.”

Drawing from perspectives across the cancer care continuum, including patient advocates, clinicians, researchers, and many more, the ASCO roundtable participants used their findings to develop a policy statement, “Addressing Financial Barriers to Patient Participation in Clinical Trials,” published in the Journal of Clinical Oncology (JCO) in September 2018.1 The statement outlines the burdensome and widespread effects of financial toxicity on people with cancer and four recommendations to properly address this barrier.

How Can We Lower the Financial Burden?

In surveying the available literature, the ASCO roundtable participants identified both a lack of transparency and gaps in coverage policy, as well as ethical, compliance, and institutional impediments to patient financial support as key areas that need to be addressed. To break down the multifaceted relationship of clinical trials and financial toxicity, authors identified three main objectives for the policy statement: making the total costs of clinical trials clearer to patients, providers, and payers; defining appropriate financial support for clinical trial participants; and improving overall research on the direct, ancillary, and indirect costs of clinical trial participation.

The four recommendations provide practical steps that all oncology professionals can take to ensure that more patients, regardless of financial status, can participate in clinical trials.

“The recommendations in ASCO’s statement aim to ensure that no patient is denied access to a clinical trial for financial reasons and that patients are not harmed financially because of their contributions to advancing science,” said Dr. Bertagnolli. “Ultimately, this is about strengthening the nation’s cancer research enterprise as a whole.”

Recommendation 1: Improve payer clinical trial coverage policies. Clinical trial cost payment policies should be revised so that they are made consistent, streamlined, and transparent to all stakeholders.

The ASCO roundtable participants observed the lack of explicit definitions for a routine cost in a clinical trial, as well as inconsistencies in prior authorization policies, and recognized a need for more uniformity and transparency. The statement also recommends that state Medicaid programs should guarantee coverage across the board for routine care associated with clinical trials, while the Centers for Medicare and Medicaid Services (CMS) should revise the requirement that Medicare Advantage beneficiaries revert to fee-for-service while enrolled in a clinical trial and use its Innovation Center (CMMI) to explore how alternate payment models support increased participation in clinical trials.

Recommendation 2: During the clinical trials development and enrollment process, provide patients with clear, transparent information about potential trial-related out-of-pocket costs, and include mechanisms to support patient financial/health literacy.

The statement recommends that clinical trial sponsors create a coverage analysis that estimates all costs, including out-of-pocket and covered costs. Then, to help navigate these clinical trial costs, research sites should consider offering or partnering with financial counseling services for patients.

The clinical trials should also, when possible, avoid additional costs that are not necessary for the scientific objectives of the trial or the patient’s safety. This includes low-value trial-specific visits or scans, among other costs.

Recommendation 3: Remove impediments to ethically appropriate financial compensation for trial-related out-of-pocket costs. Provision of such financial support should not be considered undue inducement.

Discussions at the ASCO roundtable recognized the real, but often misplaced, concerns over financially supporting clinical trial participants for their out-of-pocket costs. The statement dispels the assumption that paying for these costs would exert an influence over lower-income patients, pointing out that these reimbursements are tied solely to the clinical trial costs, not adding to the patient’s overall income. Instead, this support helps patients make independent decisions about their care that includes options previously unavailable to them. The statement recommends that the Office for Human Research Protections develop guidance for organizations interested in providing this type of financial support for patients who would be discouraged from participating because of this financial burden.

Recommendation 4: Incentivize research that will better characterize patient costs incurred for participating in cancer clinical trials and support the longer-term development of tools to identify and mitigate the risk of trial-associated financial hardship.

There is a large gap in available research on what patients with cancer on clinical trials are paying for their care—the latest applicable research only accounted for direct costs and was published almost 20 years ago. The statement strongly encourages organizations funding clinical trials to also fund studies investigating the costs of participation. The ASCO Quality Care Symposium brings together leaders in the field focused on improving measuring and implementing high quality care. This year’s symposium featured a study on the financial hardships of cancer care.5  

“From a policy perspective, ASCO continues to consistently advocate for policies that remove restrictions on patients to receive quality cancer care, including access to clinical trials,” said Dr. Moy. “From a research perspective, ASCO has highlighted important recent clinical studies that reveal the profound financial burden faced by patients with cancer at the 2018 ASCO Quality Care Symposium.”

Knowing the full cost that patients are paying for their participation can inspire further work that lowers the level of financial hardship and makes participating in a clinical trial a viable option for more patients.

“By continually bringing attention to the financial burdens patients face and the barrier that incremental costs associated with clinical trials may generate, ASCO is raising the flag and rallying the troops to band together and come up with sustainable ways to support patients from all backgrounds through their cancer journey, enabling everyone to have the option to enroll in a clinical trial without the fear of increased financial toxicity,” said Dr. Winkfield.

ASCO thanks the Lazarex Cancer Foundation for funding the 2017 ASCO Roundtable on Addressing Financial Barriers to Clinical Trials Participation, which contributed to the development of the 2018 ASCO policy statement “Addressing Financial Barriers to Patient Participation in Clinical Trials.”

References

  1. Winkfield KM, Philips JK, Joffe S, et al. J Clin Oncol. Epub 2018 Sept 13.
  2. Yabroff KR, Dowling EC, Guy GP Jr, et al. J Clin Oncol 2016;34:259-267.
  3. Altice CK, Banegas MP, Tucker-Seeley RD, et al. J Natl Cancer Inst 2016;109:djw205.
  4. Unger JM, Moseley A, Symington B, et al. JAMA Netw Open. 2018;1(4):e181235.
  5. Wheeler SB, Spencer J, Manning ML, et al. J Clin Oncol. 2018;36:32-32 (suppl; abstr 32).

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