1. DiGiulio, Sarah

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In a recent JAMA Oncology Viewpoint article, two medical ethics experts from the University of Pennsylvania argue it's time to revise how we reimburse and incentivize cancer clinical trial participation (2018;4:913-914).

Emily Largent, PhD, ... - Click to enlarge in new windowEmily Largent, PhD, JD, RN. Emily Largent, PhD, JD, RN

The authors-Emily Largent, PhD, JD, RN, Assistant Professor, and Holly Fernandez Lynch, JD, MBe, Assistant Professor and Assistant Faculty Director of Online Education, both in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at University of Pennsylvania-say reimbursement for clinical trial-related expenses will help make access to investigational drugs and treatments more equitable. In particular, access will be fairer for people of lower socioeconomic status (as trial participants often incur out-of-pocket expenses for supportive care that is not covered by the trial sponsor). Such expenses may be for travel and lodging for the purpose of participating in the trial, as well as copayments, co-insurance, and deductible payments associated with usual care received over the course of a trial.


FDA policy does not discourage reimbursement to patients for clinical trial-related expenses, and a recent policy update explicitly states it's not coercive or unduly influential to do so. Largent and Lynch suggest, however, that this stand is too narrow-and there are other permissible uses for payment including compensation for time and effort, as well as incentives to encourage patients to participate in clinical trials.


Some states have considered passing state-level laws that clarify that reimbursement of clinical trial-related expenses (such as travel and lodging) is not coercive, which, according to Largent and Lynch, is appropriate.


Oncologists and cancer care providers can (and should) be advocates for addressing these barriers to clinical trial participation, Largent explained. "People need to be aware that clinical trials are not 'free'-but the research is incredibly important."


Here's what else Largent told Oncology Times about the issue.


1 What prompted you to write this editorial and why is the issue so important now?

"This issue came to my attention because I live in a state (Pennsylvania) that is currently considering such an act [that would clarify that reimbursement for clinical trial-related expenses is not coercive]. I have been working on issues related to paying research participants for years-and most attention is focused on issues of payment at the federal level. So, this felt like a novel approach.


"A lot of cancer trials fail to enroll the target number of participants. In extreme cases, the trial may have to close prematurely; in other cases, there may be less statistical power to answer the questions of interest. If we could address financial barriers to trials, we might be able to recruit more people into trials.


"In addition, a common concern is that we want to distribute the burdens and benefits of clinical trial participation evenly over the population-and addressing financial barriers may help ensure that this distribution of burdens and benefits is more even."


2 What are the costs of participating in a clinical trial?

"There isn't typically an 'entry fee' to be enrolled in a clinical trial. And, in many cases, the investigational drug or experimental intervention will be paid for by a sponsor; and usual care will be covered by the insurer.


"However, individuals may still have to pay for travel and lodging or assume increased copayments and deductibles (on the usual care). These expenses may not be immediately obvious to trial participants but can be significant.


"People often talk about the 'financial toxicity' of cancer therapy-that is, treatment-related financial hardship. But there is increasing evidence that participating in cancer clinical trials can have additional financial toxicity, and that is not something that is discussed enough. Participating in clinical trials can require patients to assume out-of-pocket costs, such as travel and lodging for study visits or increased copayments and deductibles. This expense can be a barrier to trial participation for a lot of people."


3 Your editorial explains several options to incentivize clinical trial participation by offering payment from expense reimbursement to compensation. What do you think is the best option?

"I think that the default should be reimbursing people for out-of-pocket expenses and offering compensation for their time and effort. Although I think this is possible within existing regulations, institutional review boards may be hesitant to do this out of fear that offering payment will distort the patient's decision about whether or not to participate in research. So, it would help for the Office of Human Research Protections and the FDA to further clarify that offering payment is acceptable and even desirable. This might calm some anxiety around payment, which is an important first step."