Last week, the American Cancer Society released its annual Facts and Figures report, showing that we continue to make exceptional progress against cancer, most notably with a 27 percent decline in the death rate across all cancer types over the last 25 years.
While this is exciting news, many cancer patients are not realizing this positive outcome—either because we lack acceptable treatments for their cancer or because of the widening gaps in socio-economic status across the United States that put available treatments out of reach for some. The ACS report is a call to action to the cancer community to do all we can to prioritize policies, education, and research to help correct these persistent inequities.
My American Society of Clinical Oncology presidential theme is “Caring for every patient, learning from every patient” and I am putting these words into action. During my term, I am traveling with ASCO leaders to underserved communities around the United States to hear firsthand from patients, survivors, caregivers, and oncology professionals about the impact of a cancer diagnosis on their lives, families and communities.
What I am learning from these “town halls” is eye-opening. At every site, I meet patients who only receive their care because they are able to draw upon resources outside of our healthcare system. In Appalachia, I visited a clinic where the equipment required for cervical cancer screening was purchased using funds raised by community bingo and “poker runs.” In Puerto Rico, courier services donate their drivers, vans, and precious gasoline to shuttle patients to infusion centers, even now, 16 months after Hurricane Maria.
These visits are heart-warming and heart-breaking. At every meeting is a story of dedication, resourcefulness, and community support to meet the needs of cancer patients. This illustrates a central dilemma that we face: how to structure our healthcare system so that each unique community has what it needs to support the patients and providers of cancer care.
We cannot solve complex problems without understanding them, and understanding requires information: data from the clinical setting. It is time to give every patient the opportunity to participate in research and contribute to progress. ASCO is working toward this mission in a number of areas, including expanding eligibility criteria for clinical trials and removing financial barriers to broaden clinical trial participation.
It is time to give every patient the opportunity to participate in research and contribute to progress. ASCO is working toward this mission in a number of areas, including expanding eligibility criteria for clinical trials and removing financial barriers to broaden clinical trial participation.
I once heard someone say the only participants in cancer clinical trials are marathon runners who have cancer and happen to live in cities with large cancer centers. Notwithstanding the hyperbole, the fact remains that clinical trial participants differ significantly from the greater population of cancer patients, especially as it relates to race, ethnicity, and age.
This potentially makes the results of our research less applicable to treating more diverse patient populations seen in clinical practice. We know from many studies involving cancer patients that the greatest determinant of whether a patient participates in a clinical trial is whether their physician discusses participation. While there are many reasons that trial participation by both clinicians and patients is low, we need to do what we can to encourage clinicians to enroll patients and make it easier to participate in research.
A major barrier to clinical trials access is stringent eligibility criteria, leading to fewer patients qualifying to participate. Cancer researchers and sponsors have a responsibility to broaden eligibility criteria for clinical trials participation in order to rectify this issue. ASCO, Friends of Cancer Research, FDA, NCI, the NCI Cooperative Groups, and many other stakeholders are working to increase the diversity of clinical trial participants by broadening eligibility criteria.
In 2017, ASCO and Friends released a joint research statement that recommends specific strategies to change the exclusionary nature of eligibility criteria. We developed these consensus recommendations with expert working groups that broadly represent the cancer community for eligibility criteria on brain metastases, HIV/AIDS, Hepatitis virus infection, organ dysfunction, prior and concurrent malignancies, and minimum age for enrollment.
Additionally, in August of 2018, we submitted recommended language to the FDA for guidance documents on ways to broaden eligibility criteria in these five areas and later that year, the NCI revised its protocol template to broaden eligibility criteria in these areas for NCI-sponsored clinical trials.
ASCO also issued a policy statement that lays out a series of recommendations that are designed to address financial barriers because even if a patient qualifies for a trial, he or she may not be able to afford participation. A range of financial barriers can impede access to clinical trials, including lack of health insurance, inconsistent insurance coverage of a trial’s routine care costs, and non-healthcare costs associated with trial participation (such as travel, housing, time off work).
In 2017, ASCO’s Health Equity Committee convened a Roundtable to define the scope of the problem and identify both clinical practice and policy solutions. Findings from the ASCO Roundtable and published literature culminated in ASCO’s policy statement on addressing financial barriers to clinical trials participation. It includes four recommendations for overcoming financial barriers.
Improve payer clinical trial coverage policies. Reimbursement policies for routine care provided in clinical trials should be revised so that they are made consistent, streamlined, and transparent to all stakeholders. For example, the CLINICAL TREATMENT Act, bipartisan legislation introduced in the last Congress, would require Medicaid to cover the routine costs of clinical trials. We are advocating for that bill to be reintroduced in this Congress.
Involve patients during the clinical trials development process to ensure that the design accommodates their potential concerns and—during the enrollment process—provide patients with clear, transparent information about potential trial-related out-of-pocket costs. Include mechanisms to support patient financial/health literacy.
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. Fortunately, the FDA released an information sheet in January 2018 to clarify that providing payments to trial participants is generally an acceptable practice.
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.
Improving the diversity of clinical trials participation is vitally important, but it is just as crucial that the benefits of our knowledge be accessible to all. As the ACS researchers note, disparities in cancer risk, detection, treatment, palliation, and survivorship are due to long-standing inequalities in socioeconomic factors.
Indeed, researchers throughout the medical community now routinely acknowledge that a person’s zip code is perhaps the greatest predictor of health status. Ten years ago, ASCO issued its first policy statement on disparities in cancer care in recognition of the fact that the benefits of our growing knowledge of cancer biology are not being made equitably available to all. The statement called for a multi-pronged effort to enhance the awareness of disparities, improve access to care, and support research on health disparities.
Since that time, there has been some improvement in access to high quality care. For example, provisions in the Affordable Care Act have been established to reduce these disparities. We have recognized the importance of a diverse oncology workforce to improved access for the underserved and we have made progress increasing that diversity. Despite progress, inequalities persist, both systemic and barriers related to patients and their providers (including educational or communication gaps) that threaten optimal care.
Considerable work remains to give every patient the opportunity to participate in, and benefit from, cancer clinical trials, but it is a task that all oncologists must embrace. We owe it to our patients and our field to give everyone a chance to contribute to research that increases our understanding of and leads to better treatments for cancer.
