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3 Questions on…

Answers straight from the experts on the latest news and topics in oncology

Friday, October 5, 2018

With Emily Largent, PhD, JD, RN, at the Perelman School of Medicine at University of Pennsylvania

By Sarah DiGiulio

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).

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."

Friday, September 21, 2018

With Lindor Qunaj, BSc, of the Warren Alpert Medical School of Brown University

By Sarah DiGiulio

If a clinical research trial showed that an oncology drug you were prescribing to your patients had a previously unrecognized adverse side effect, how soon would you want to know? Would you prefer to know as soon as the data was available—or 300 days later?

Oncologists and other members of the cancer care team would presumably want that information sooner rather than later to be able to more appropriately prescribe those drugs and take care of their patients. But new data that reviewed 100 pharmaceutical company-sponsored clinical trials shows that the median delay from when results are available to publication of complete data was 300 days, with negative findings taking longer to reach the public. The study was recently published online in JAMA Oncology (2018; doi:10.1001/jamaoncol.2018.0264).

"The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry," the researchers noted in the study. "Even for the most pressing study findings, median publication delays approach 1 year."

The median delay for trials reporting negative trial data was 407 days. Though previous studies have investigated delays in the publication of clinical trial data, this new study used novel criteria for selecting trials for the analysis. The researchers only looked at phase III industry-sponsored trials for which the drug company had issued a press release about the results.

"Industry-sponsored phase III trials examining novel therapeutics have some of the greatest potential to shape practice guidelines and research programs in oncology," explained study coauthor Lindor Qunaj, BSc, a medical student at the Warren Alpert Medical School of Brown University. "These studies also offer a clear proxy—in the form of a press release—for the time at which data is sufficiently processed to draw a directional conclusion."

The study measured the duration from when a press release announcing trial findings was issued until that data were posted on or published in a medical journal.

The eight drug companies from which sponsorship of the clinical trials analyzed in this study come collectively accounted for 72 percent of all oncology drug sales in 2015, according to the study.

In an interview with Oncology Times, here's why Qunaj says these findings are so important.

1. What were the key findings from this new research and why are they so important now?

"Even for clinical trials expected to have an important effect on patient care and scientific innovation in the field of oncology, delays in meaningful data release are considerable. These delays are significantly longer for studies reporting negative (compared to positive) results.

"Delayed or incomplete release of clinical trial results forces providers to make treatment decisions based on limited information, potentially putting patients at risk of newly discovered toxicities—or not offering interventions that may prolong survival.

"It also causes companies and researchers to shape their research agendas with incomplete data, which can lead to duplicative studies and slow the overall pace of medical innovation. Our study sought to better characterize the magnitude of these delays."

2. Given the delays in the publication of clinical trial results that you've identified, what's the next step in moving the needle to actually improve the situation?

"Our research suggests the scientific community has a long way to go in improving the speed and completeness of clinical trial data releases. We recommend 1) placing a greater emphasis on prepublication, and 2) more strictly enforcing data posting requirements on databases, such as, as two potential approaches for change. But we recognize that these suggestions are just a start.

"Any strategy designed to facilitate rapid and thorough data dissemination will need to secure buy-in from journals, regulatory agencies, conference organizers, and industry sponsors to be broadly effective. Because these varied stakeholders often have competing interests, creating integrated solutions may be difficult, but should be a priority—not just in oncology—but across the biomedical community. In the meantime, both patients and the pace of scientific innovation will continue to be negatively affected."

3. Do you plan to do any follow-up investigation in this area?

"A natural follow-up from our study would be to estimate the effect data delays have on patient outcomes. How many patients are being treated with incomplete information each day, and how would their management have differed if that information were available? While these calculations would be decidedly difficult to perform, the conclusions could serve as even more convincing arguments for systemic policy change."​

Wednesday, September 5, 2018

With Sheila Prindiville, MD, MPH, Director of the Coordinating Center for Clinical Trials at NCI

By Sarah DiGiulio

The NCI and the Department of Veterans Affairs (VA) recently announced an agreement that outlines specific ways the agencies will collaborate to boost veterans' access to cancer clinical trials.

The initiative is called NAVIGATE, which stands for the NCI and VA Interagency Group to Accelerate Trials Enrollment. And a key facet of the agreement is that NCI will provide more infrastructure to help the VA better participate in NCI-sponsored trials.

NAVIGATE will also allow for more VA investigators to be involved in clinical cancer research and provide more opportunities for these investigators to determine what research is needed, including ones of particular importance to veterans with cancer.

"This agreement will not only provide veterans greater access to NCI clinical trials, it will enhance accrual to NCTN [National Clinical Trials Network] and NCORP [NCI Community Oncology Research Program] trials, resulting in more timely completion of these studies. This interagency collaboration will also work to help veterans overcome barriers they've faced trying to access clinical trials as part of their cancer care," noted James H. Doroshow, MD, NCI's Deputy Director for Clinical and Translational Research, in a press release.

In the recent agreement, NCI and the VA agreed to jointly manage the new program for up to 3 years. The participating sites are expected to establish best practices and share insights as they go to help other VA sites nationwide initiate new research and increase veteran enrollment in cancer clinical trials.

In an interview with Oncology Times, Sheila Prindiville, MD, MPH, Director of the Coordinating Center for Clinical Trials at NCI, explained more about the goals and specifics of the program.

1. What is NAVIGATE and how will it change how NCI and the VA work together on cancer clinical trials?

"NAVIGATE is a partnership between NCI and the VA to make it easier for veterans to access state-of-the-art treatments through NCI-supported clinical trials directly at VA sites, rather than seeking treatment outside of the Veterans Health Administration.

"It's a 3-year collaboration between NCI and the VA to facilitate enrollment of veterans into NCI-funded clinical trials. It's also an opportunity for government agencies long committed to veterans' health to partner at the national level to make clinical trials more accessible. This strategic partnership was prompted by the observation that fewer veterans were participating in NCI-supported clinical trials than in the past. One of the reasons identified was the lack of infrastructure support for dedicated clinical research staff.

"NAVIGATE is a win–win initiative. It will make it easier for veterans with cancer to receive the newest treatments and increase their participation in NCI-supported clinical trials. The increased participation should allow the trials to be completed more quickly and new treatments to become available sooner."

2. But the VA had already been conducting clinical trials in cancer. Can you explain how the agency had been collaborating with NCI, if at all?

"The VA offers clinical trials in many disease sites, including cancer. Historically, the VA had a role in the establishment of multisite clinical trials for evidence-based practice starting in the 1940s. The [agency] conducts cancer clinical trials sponsored by the NCI, as well as [trials sponsored by] other organizations such as industry, academia, and other partners. The VA will continue to conduct trials with these partners, including NCI, as it has done in the past.

"What is new is that NCI is providing funding to the VA through NAVIGATE so that sites have support for dedicated research coordinators specifically for NCI-funded trials. Additionally, the program will utilize a centralized approach coordinated by the VA Cooperative Studies Program to address site-level and system-wide challenges to trial activation and enrollment."

3. Can you share any specifics about how NAVIGATE is being rolled out?

"Twelve VA sites are participating in the program and will receive funding for dedicated clinical research staff to assist with the conduct of clinical trials. At each site, a VA principal investigator will oversee the NAVIGATE activities.

"The VA Cooperative Studies Program, Office of Research & Development, and the NCI Coordinating Center for Clinical Trials will provide coordination and management for NAVIGATE.

"A steering committee consisting of VA and NCI staff will use a centralized approach to address system-wide and site-level challenges to trial activation and enrollment.

"An executive committee consisting of NCI, VA, and NCTN senior leadership will monitor the overall progress and direction towards meeting the NAVIGATE program goals."

Monday, August 20, 2018

With Rebecca Siegel, MPH, at the American Cancer Society

By Sarah DiGiulio

The American Cancer Society (ACS) recently published the first in a series of articles outlining the organization's vision for where cancer control can and should go between now and the year 2035. Although much has been done in the areas of cancer prevention, detection, and treatment, there is a lot more that can be done, according to the report published in the journal Cancer (2018; doi:10.3322/caac.21460).

The strategy to lower the cancer burden nationally by 2035 involves using targeted interventions to reduce the prevalence of cancer risk factors (smoking, obesity, and others), as well as facilitate delivery of high-quality prevention, early detection, and treatment services to low-income communities, according to Rebecca Siegel, MPH, Scientific Director of Surveillance Research at the ACS and a coauthor of the report.

"These articles outline our organization's vision on the most efficient path to lower the cancer burden in our nation," Siegel shared with Oncology Times. "It is our hope that they will be a call to action for professional organizations, government agencies, the medical profession, academia, and industry to work together to implement what is known about cancer control and create a national cancer plan."

ACS will publish subsequent articles over the next several months that focus on cancer risk factors, screening, treatment, survivorship, and research, she noted.

The evidence upon which the recent ACS report was developed comes from population-based data gathered by registrars working in treatment facilities across the U.S., as well as CDC cancer registries and ones funded by the NCI. The Surveillance, Epidemiology, and End Results (SEER) program at the NCI includes data from 28 percent of the U.S. population, according to the report.

Here's what else Siegel said about the cancer control plan and the data outlined in this report.

1. Several of the strategies that ACS plans to bolster involve not necessarily fancier drugs or expensive new equipment, but rather better utilization of tools already at our fingertips. Why this approach?

"These strategies can help facilitate cancer control among our most vulnerable populations who do not currently benefit from all the known strategies for prevention, early detection, and treatment.

"Most cancer disparities are because of poverty. In general, people with lower socioeconomic status have a higher prevalence of cancer risk factors, such as smoking, obesity, an unhealthy diet, lower levels of health literacy and awareness, and less access to preventive care and high-quality treatment.

"Almost one-fourth of all cancer deaths could be averted if everyone had the same cancer death rates as those who are college-educated. (Education is used to approximate socioeconomic status because it is the only individual population-level socioeconomic marker available on death certificates.)"

2. One interesting data point in the report is that 22 percent of all cancer deaths would not occur if all Americans had the cancer death rates of college-educated Americans. In your own words, why is that point so significant?

"Educational attainment is used to approximate socioeconomic status because it is the only individual population-level socioeconomic marker available on death certificates. In general, people with lower socioeconomic status have a higher prevalence of cancer risk factors, such as smoking, obesity, and unhealthy diet, [as well as] lower levels of health literacy and awareness and less access to preventive care and high-quality treatment—resulting in higher cancer incidence and death rates.

"If people at all levels of the socioeconomic ladder experienced the same benefit of advances in cancer control as the people at the top, more than one in five cancer deaths could potentially be prevented."

3. What would you say is the most important message for practicing oncologists and the oncology care community to know about this new report and the aims of what the 2035 cancer control goals will be?

"Much of the work in reducing the cancer burden can be accomplished now, with the information we already have in hand, by ensuring that known strategies for cancer prevention, early detection, and treatment are disseminated to all Americans and not just those who are at the top of the socioeconomic ladder.

"[Some of the biggest barriers to accomplishing these goals are] a national desire for health equity and financial and human resources."


Monday, August 6, 2018

With Michelle Mollica, PHD, MPH, RN, OCN, of the National Cancer Institute

By Sarah DiGiulio

Past research has suggested that patients with cancer who live in rural areas have a delay in accessing the cancer care services they need compared with patients with cancer who live in urban areas. But a new study that examined more recent data found that paradigm may be changing.

The new findings suggest that rural cancer survivors report more timely care than those in urban areas; but regardless of residence in an urban or rural area, individuals who were of a racial or ethnic minority still reported challenges accessing timely care (Cancer 2018; doi:10.1002/cncr.31541).

"After we controlled for key patient variables and cancer-related variables, we actually found a significant association between residence at diagnosis," stated Michelle Mollica, PhD, MPH, RN, OCN, Program Director in the Outcomes Research Branch of the Healthcare Delivery Research Program at the NCI, during an interview with Oncology Times. "Those that lived in urban areas rated their timeliness of care lower than those in rural areas. We did not see a significant interaction with the access to care measure.

"In the measure of access to care, rural non-Hispanic white respondents rated their access to care almost two points higher than those in urban areas. But we found a different trend for non-Hispanic black and Hispanic respondents—those in rural areas rated their access to care lower," Mollica explained.

For the study, researchers looked at patient experience survey data for 6,140 cancer survivors who identified as urban and 686 who identified as rural. All the individuals whose replies were part of the study were Medicare beneficiaries. The surveys were collected between 1998 and 2013 as part of the Surveillance, Epidemiology, and End Results-Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) linked data during the patients' course of treatment and care.

The study examined replies to the surveys in which respondents ranked "Getting Needed Care" and "Getting Care Quickly" over the past 6 months of their care. It was the latter question that urban cancer survivors were more likely to rank lower than rural cancer survivors. And while there were no significant differences for "Getting Needed Care" between urban and rural cancer survivors, both people who were non-Hispanic black and Hispanic ranked that measure lower than others did.

Here's what else Mollica told Oncology Times about the findings and what they mean about how best to improve access to care for both urban and rural patients with cancer.

1. These new findings are somewhat different than what previous studies have shown. Were you surprised by that?

"Based on the literature and based on lots of previous work, we anticipated that there would be issues with access to care for those that lived in rural areas. We thought we would see a similar trend here. And we actually found the opposite.

"It's possible that reports of timeliness of care are due to ability to obtain a provider referral, identify a provider or availability of an appointment, or to get to the health care provider. So it's possible that urban residents experience barriers that rural residents in the sample did not.

"It's also possible that rural residents have different expectations. So, they perhaps may be willing to travel farther for their care. And also we have had some substantial advances in telehealth and technology that have improved care for rural residents—and perhaps for urban residents we have to consider that as well.

"The CAHPS survey itself has very specific measures in terms of timeliness of care, such as did you get the care when you thought you needed it, but we don't have questions on transportation and other sort of fine-grained aspects of accessing care.

"So we really feel like future work should look into this in a more specific way."

2. Does the data suggest access to care in rural areas has improved (given that other data suggests they had worse access to care)—or is that too simple a read on the findings?

"There are nuances to this story, but that's not to shortchange the fact that they have made several advances in telehealth and in technology in rural areas.

"I think that we need to also be considering those types of technologies for areas that are more urban. So it's very possible this is part of the story and perhaps lays the groundwork for future research.

"It's going to be really important to consider rural [versus urban residence], as well as race/ethnicity when looking at perceived access to care. We've seen lots of disparities among race/ethnicity in cancer incidence, among other things. But specifically, how we are addressing disparities and access to care is an important next step.

"We also need to be considering innovative cancer care delivery tools for those that are in urban areas. I think sometimes we forget that urban areas may have higher volume and longer wait times because there could be more people and more crowded clinics."

3. What would you say are the most important takeaways about this research for cancer care providers treating patients every day?

"I'm an oncology nurse as well as a researcher. I think that one of the things that oncology providers do a great job of is treating the whole patient. But in doing so I think it's important to consider barriers to access within urban areas, as well as rural areas. We may need to broaden our view to the barriers that people might be experiencing even in more populated areas."