Editor’s note: Dr. Hudis hosts the ASCO in Action Podcast, which focuses on policy and practice issues affecting providers and patients. An excerpt of a recent episode is shared below; it has been edited for length and clarity. Listen to the full podcast online or through iTunes or Google Play.
I'm really delighted to have Beverly Moy, MD, MPH, joining us. Dr. Moy is a medical oncologist at the Massachusetts General Hospital who specializes in breast cancer care. She's also an associate professor of medicine at the Harvard Medical School and a longstanding and dedicated ASCO volunteer. She led the ASCO roundtable on addressing financial barriers to clinical trials, and she was one of the authors of ASCO's policy statement providing recommendations to address this important issue. So our conversation today will focus on the existing financial barriers to patient participation in clinical trials and how policymakers, trial sponsors, institutional review boards, and other stakeholders can help remove and overcome those barriers.
CH: By way of background for our audience, only a small percentage of patients with cancer ever participate in clinical research. And yet, we know that certain groups, especially people from low socioeconomic status, are underrepresented even in those trials. To give a little bit of shape to that, no more than 3% or 4% of adults with solid tumors participate in research studies. And even then, that number over-represents certain higher socioeconomic groups and underrepresents others. Can you tell us why this issue is important to be addressed, and, furthermore, how we might improve the diversity of clinical trial participation?
BM: I think it's incredibly important to improve clinical trial participation among underserved groups. When I think about how we can provide the highest quality cancer care, we really can deliver three basic things: the best possible standard cancer therapy, the best possible supportive and palliative care, and the best possible novel or experimental therapy. We know that clinical trials are crucial to the advancement in cancer care, and in the current genomic era, sometimes these trials may even represent the best possible treatment option for some of our patients with cancer. We also know from the medical literature that patients who participate in clinical trials tend to do better and sometimes even live longer.
When access to the best possible experimental therapy is threatened, optimal cancer care becomes impossible due to financial barriers. This is an example of social injustice, where poor or underserved patients are being deprived of quality cancer care. So I think that improving the diversity of clinical trial participants is also critically important. That's a longstanding issue, and I know that many listeners are appreciative the efforts to address it. But it raises a question about the underlying reason for this. And one of them, I think, is financial, that is financial barriers to participation, financial barriers to care, and what is now called financial toxicity. As an aside, we recently conducted a national cancer opinion survey and one of the striking observations this year was that 57% of Americans say that if they received a cancer diagnosis, they would be most concerned about financial impact or paying for treatment. That was compared to 54% who said they'd be most concerned about dying or suffering from the diagnosis. I think it's a remarkable statement that at least a large proportion of people think first and most profoundly about the financial implications of a cancer diagnosis as think about the health consequences.
CH: If we think about that and then turn back to the clinical trial situation, it is, I think, true that most clinical trial participants will have to face even more additional costs that may prevent them from participating in trials. Can you provide us with an overview of what some of those additional costs are that participants face when they consider a clinical research setting?
BM: You're absolutely right. The general financial burden that any patient with cancer faces is incredibly high. And I actually would reference listeners to listen to your podcast that you did after the ASCO Quality Care Symposium, where you actually talked about a few studies looking at really the high rates of financial burden that patients just generally diagnosed with cancer faces. When you add the complexity of participating in a clinical trial, not only do you have that general financial burden that a patient with cancer has, but you add additional potential financial costs that become prohibitive for our poor and underserved patients. I think of these additional costs related to clinical trials as falling into really two basic categories. One is gaps in insurance coverage, and then the second is non-medical out-of-pocket costs.
Picking the gaps in insurance coverage policies category, we know the Affordable Care Act was passed in 2010, and it does require coverage of routine health care costs for patients participating in clinical trials. But these protections do not extend to patients with Medicare or Medicaid. It's only for patients with private insurers, and there are even restrictions there, which we can go into later. That means our poorer or older patients are more vulnerable to not having these protections.
These potential costs could consist of things like investigational care costs, such as a specific therapeutic drug under investigation, or more likely the cost of additional services that would not have been required if the patient was receiving standard therapy. These services could be things like extra blood draws for safety data or imaging studies that fall outside of the routine staging exams. These extra services have the danger of either being billed to the patient or forcing the patient to pay more towards their insurance premium due to policies that increase cost sharing to patients in the modern era.
A second important cost category, which is just as important, if not more important, would consist of non-medical out-of-pocket costs resulting from clinical trial participation. These costs include travel and lodging expenses, or costs due to lost wages because patients have clinical trial visits, or the need to pay for childcare because patients have to come into the hospital or the cancer center more often. Patients participating in clinical trials often have far more frequent visits than standard therapy, perhaps at centers that are farther away from their home. If they participate in early-phase first-in-human trials, they could require longer days of things like pharmacokinetic testing that might even require overnight stays in hotels. So these out-of-pocket costs can be considerable, and prohibitive, and make it impossible for poorer patients to enroll into clinical trials.
CH: I know, and I'm sure many of our listeners know, that you're actually a day-to-day clinician: you see patients with breast cancer, as well as do research at MGH. I'm interested in the practical ways that you might have seen these costs directly affect your patients. Do patients ask about trial costs when you're talking about studies with them? Have you ever had patients hear about a study and then declined to enroll because they thought it would be too expensive?
BM: In the past, when we've presented clinical trials to patients, the idea of costs never really came up maybe because it was something that patients didn't feel comfortable bringing up to their physicians. But now, either costs are becoming more considerable, or it's being raised into awareness that I think that patients are much more comfortable talking about it, maybe not at first, but maybe towards the end of the process. In my own practice, I've seen people bringing it up more and more, usually even during the consenting procedure when you're talking about all the extra visits and studies that the patient may need to have to undergo the clinical trial. I've also seen patients who've actually enrolled in trials, and they're on study, and they consider even coming off trial because they didn't anticipate some of the costs that might happen.
CH: What do you think ASCO's next steps on this issue should be? What do you propose?
BM: I think ASCO ought to demand change through federal regulatory policy fixes, and disseminate (and possibly even fund) relevant research. I think what we're doing today with this podcast is increasing awareness of this issue, which is also something that ASCO is doing, and no one can do better. I would want listeners to become really more aware of this issue.
The most underserved patients in the United States are being deprived of one of the most important types of cancer treatment options. This is a social injustice that absolutely needs to be corrected, and we need the oncology community to be united in solving this problem.
CH: I want to remind everybody that at ASCO, we are committed to preserving and enhancing access to high-quality cancer care for all individuals with cancer. Our statement on financial barriers to clinical trial participation is just one of many where ASCO's voice and the collective voice of our members are, we hope, helping to share and shape the future of the cancer care delivery system.