In keeping with her Presidential theme of “Equity: Every Patient, Every Day, Everywhere,” in July, ASCO President Lori J. Pierce, MD, FASTRO, FASCO, announced the Society was joining forces with the Association of Community Cancer Centers (ACCC) to increase racial and ethnic minority participation in cancer clinical trials. Studies of cancer treatment trials have showed that only between 4% and 6% of trial participants are Black and between 3% and 6% are Hispanic, even though they represent 15% and 13% of all patients diagnosed with cancer, respectively.1,2
The aim of the initiative is to cull ideas from the cancer community to identify and implement novel—and workable—strategies to address the longstanding barriers preventing minority patients from enrolling in clinical studies and to improve their survival rate. These barriers include provider bias, challenges with access to trials, insurance coverage, lack of trust in the health-care system and in cancer research, and cost of care among others. Black Americans bear a particularly disproportionate share of the cancer burden, including having the highest mortality rate and lowest survival rate of any racial or ethnic group for most cancers.3
Lori J. Pierce, MD, FASTRO, FASCO
The collaboration between ASCO and ACCC is a natural fit, according to Dr. Pierce, because the two organizations are committed to ensuring access to high-quality oncology care for every patient with cancer, including minority patients.
‘Stronger Together’
“Randall A. Oyer, MD, ACCC President, is focused on how community oncology can close the gap on participation in cancer research, specifically focusing on underserved populations, and my presidential tenure is focused on patient equity. So, much of what we want to do is the same, and we thought we are stronger together than we are apart, and that’s how we came together on establishing this initiative,” said Dr. Pierce.
The ASCO-ACCC Request for Ideas: Novel Strategies and Practical Solutions to Increase Participation of Racial and Ethnic Minority Populations in Cancer Treatment Trials was issued on July 21, 2020, and the deadline for responses was August 24, 2020. Members of the ASCO-ACCC Steering Committee will choose ideas for the organizations to pursue, either together or independently, using the following criteria:
- Quality of the novel strategy or practical solution
- Potential to address barriers to racial and ethnic participation in cancer treatment trials
- Potential replicability, as well as ability to disseminate and implement
- Feasibility of the project, including methodologies/approach, timeliness, resources, funding, and preliminary evidence of success
- Indications that the submitter is a program champion and has a demonstrated commitment to quality and equitable cancer care and to addressing racial and ethnic disparities in clinical trials.
Need for Bolder Steps
The pursuit of health equity for all patients with cancer is such an integral part of ASCO’s mission that, on August 12, 2020, ASCO issued its second policy statement on cancer disparities and health equity.4 The updated statement focuses on four main areas of oncology care:
- Ensuring equitable access to high-quality care, including Medicaid expansion in all states; advocacy against policies that threaten access to care, such as work requirements and other coverage limits; alternative payment models for oncology providers and financial assistance programs for patients; and new collaborations among providers, payers, employers, and other stakeholders
- Ensuring equitable access to research through the adoption of clinical trial recruitment strategies that consider patients’ socioeconomic status, race/ethnicity, or location; collection and public reporting of research data on race/ethnicity, sexual orientation, gender identity, and other variables that influence outcomes; reduction of financial and other barriers to trial participation
- Addressing structural barriers to equitable care through institution-level efforts to rectify implicit and explicit biases or discrimination toward patients, families, or health-care providers; sustained efforts to increase diversity in the oncology workforce; and partnerships with local communities and legislatures to apply research findings to improve health equity
- Increasing awareness and action through public awareness and education campaigns; collaborations among oncologists, patients, and advocacy groups to drive action; and engagement with local and national policymakers to achieve implementation of proven solutions.
“Our patients need us now more than ever to be champions for equity in cancer care. We have to be willing to take bold steps to overcome the barriers to progress against this disease,” said Dr. Pierce.
In a wide-ranging interview with The ASCO Post, Dr. Pierce, Professor of Radiation Oncology and Vice Provost for Academic and Faculty Affairs at the University of Michigan and Director of the Michigan Radiation Oncology Quality Consortium, and Co-Chair of the ASCO-ACCC Steering Group, discussed her goal to ensure that every patient with cancer has access to high-quality cancer care.
Barriers to Clinical Trial Participation
What is the process for reviewing the ASCO-ACCC Request for Ideas submissions, and what are the criteria for choosing an idea to potentially implement?
We want to know the barriers preventing ethnic and minority patients from participating in clinical trials, particular ideas to address them, and the feasibility of scaling such ideas more broadly. There have been many suggestions for overcoming these challenges, but if they are too costly or labor-intensive, they will be difficult to put into effect.
We also want to know whether the idea targets a specific population or is more generalizable across minority groups, because underrepresented minorities consist of a diverse range of individuals—and types of barriers. Although this effort is focused on increasing participation by Blacks and Hispanics who are underrepresented in clinical trials, we hope it will also have the effect of increasing trial participation of all patients with cancer. Feasibility of implementation is critical, including the potential resources and staffing required. We are thinking about all practices in which oncology research takes place and what our organizations can do to help practices improve representation in research.
We are anticipating that this effort will not result in a one-idea solution. We know one size does not fit all when it comes to increasing patient participation in clinical studies. It would be wonderful to have a toolkit of ideas that oncology practices could deploy, depending on the unique needs of their communities and practices.
“It would be wonderful to have a toolkit of ideas that oncology practices could deploy, depending on the unique needs of their communities and practices.”— Lori J. Pierce, MD, FASTRO, FASCO
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When do you expect to have some solutions to increasing minority patient enrollment into clinical trials ready to put into effect?
The submission deadline is August 24, and the steering committee will have a follow-up meeting to discuss the submissions. We are planning to have decisions on which of the submitted approaches to pursue by the end of the year and hope to start the evaluation phase in early 2021.
We look forward to a robust set of responses from the Request for Ideas for discussion, but in addition, we have an amazingly talented group of people on the steering committee—people who have worked much of their careers in this area and have great insight. We are eager to hear their ideas as well. Also, ASCO and ACCC are analyzing evidence from already published research in this area, and that will be another great source of potential successful strategies for improving minority participation in clinical trials. So, we have three different avenues to cull ideas for moving forward on this initiative.
Strategies for Improving Minority Participation in Clinical Trials
There are myriad reasons for the historically low rates of clinical trial participation by racial and ethnic minority patients, including mistrust of the medical establishment and the lingering history of the horrific Tuskegee syphilis experiments on Black men, cultural bias, and patient exclusion in clinical trials due to comorbid conditions. In addition to the ASCO-ACCC initiative, please talk about how ASCO is working to mitigate these barriers to cancer care, and what progress you are seeing?
ASCO has been working from many different perspectives to try to minimize the barriers you cited. ASCO recently issued its updated policy statement on achieving cancer care equity,4 and one area we are focusing on is advocating for patients. There is no question that social determinants of health are contributing to health-care disparities in minority patients, and it is important to make Congress aware of these barriers, so steps can be taken to mitigate them.
“There is no question that social determinants of health are contributing to health-care disparities in minority patients.”— Lori J. Pierce, MD, FASTRO, FASCO
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One example of our advocacy efforts is our work to pass the CLINICAL TREATMENT Act (H.R. 913), which would require state Medicaid programs to cover routine care costs for services provided to patients participating in clinical trials. Nearly 60% of eligible Medicaid recipients identify as Black, Hispanic, American Indian/Alaska Native, and other minority populations, but if Medicaid does not cover the routine care services of clinical trials, that acts as a disincentive to participation. ASCO is very involved in improving access to clinical research and high-quality cancer care, not just for minority patients, but for all patients with cancer.
Another way we are working to improve care for patients is through outreach to underrepresented minorities in medicine, beginning with medical students, to increase oncology workforce diversity. We know it is worthwhile for many reasons to have a diverse workforce. For one, it is important for patients to see physicians who look like them, and it’s also important for physicians to bring diverse experiences and backgrounds to the field of oncology.
Since 2008, ASCO has had its Diversity in Oncology Initiative, which provides mentorships with an oncologist and stipends for minority medical students to attend ASCO’s Annual Meeting. It also supports clinical research oncology rotations, so students can see what ASCO membership offers, and, more important, what the field of oncology is all about. We have similar programs for residents of color to encourage them to choose oncology as a specialty.
In another area, we know that if eligibility criteria are too rigid, they will limit the patients who can take part in clinical trials, which in turn limits our ability to understand how the drug will affect the broader patient population that ultimately uses it. If you have underrepresented minorities who have overcome the barriers for enrollment and want to go into a trial, but they are then turned away because of the eligibility criteria, that’s a real problem. Now, some eligibility criteria must be in place to discern whether the investigational drug is appropriate for specific patients, but many criteria are historical holdovers and should be reconsidered. We can relax these criteria and still preserve the quality of our results. Our approach to clinical trials should be one of inclusion, where we exclude patients only if there are concerns about safety and scientific integrity.
ASCO, the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), and Friends of Cancer Research (Friends)—working together—have made significant strides in broadening eligibility criteria to the point where the NCI has now changed its generic protocol template for NCI-sponsored trials. In addition, the FDA provides guidance that industry is expected to follow regarding more liberal eligibility criteria.
For example, the FDA has widened the eligibility criteria for patients who have active or treated/stable brain metastases. The agency has also broadened eligibility for patients with organ dysfunction; prior or concurrent malignancies; and/or HIV, hepatitis B, or hepatitis C virus infections; as well as guidance for the inclusion of adolescent patients into adult oncology trials. ASCO and Friends have approved new recommendations for broadened criteria that are currently being submitted for publication. It’s a very positive step in the right direction. This will be a huge change for all patients going on clinical trials and certainly for underrepresented minorities as well, provided sponsors use the broader criteria and investigators and research staff discuss trials with patients.
Using Scientific Data to Encourage COVID-19 Vaccinations
In addition to cancer, Blacks are also at higher risk of contracting and dying of the coronavirus than non-Black individuals. A recent poll in The Washington Post found that only 32% of Black adults said they would definitely get vaccinated when a coronavirus vaccine is available, compared with 45% of White and Hispanic adults.5 Does ASCO have plans for outreach in Black communities to encourage COVID-19 vaccinations for patients with cancer?
I can’t say specifically how ASCO will respond when a vaccine is available, but I’m sure the response will include robust messaging to all its members. ASCO has been very active in providing resources to our members during the pandemic through its website, e-mails, and podcasts, so we would certainly work with our Health Equity Committee members and our Cancer Prevention Committee members for ways to reach all members and their patients once a vaccine is approved. And that certainly would include patients of color.
I also think there will be robust public health messaging across other medical societies, and ASCO will be very involved in that as well. Science must lead this effort to assure patients that vaccines for the coronavirus will receive FDA approval only once randomized clinical trial data show they are safe and effective. If we as clinicians take the time to explain to people that the process for vaccine approval has been appropriately followed and has not been short-circuited, I’m hoping the data from The Washington Post will not be relevant.
If data show a vaccine’s efficacy and safety and that information is messaged appropriately, I don’t anticipate there will be a differential in terms of who receives the vaccine.
Addressing Systemic Racism in Medicine
In your statement “Responding to Racism and Health Inequality as a Cancer Care Community,” you called on the oncology community to confront and address the complex forces and systems that have created disparities in cancer prevention, diagnosis, treatment, and research.6 Please talk about new commitments ASCO is planning to help dispel structural racism in medicine.
Health equity reduces the effects of racism, so ASCO has always focused, and continues to focus, on providing strong support for high-quality cancer care. What we want to do this year is to continue the work ASCO has been doing and augment it. Certainly, our advocacy effort to pass the CLINICAL TREATMENT Act (H.R. 913) discussed previously will strike at the heart of racism by improving access to cancer care.
Health equity is one of the reasons Dr. Oyer and I are so excited about the ASCO-ACCC initiative to increase enrollment on clinical trials. If you can create an environment where underrepresented minorities have greater access to clinical trials, you have a level playing field and can give everyone the opportunity for high-quality care.
ASCO is also planning an initiative to further expand the ability of medical students of color to learn more about the field of oncology and the wonderful avenues of research and clinical care that improve the lives of our patients.
Another initiative I’m very excited about will expand our knowledge of the social determinants of health, which underscore a lot of the inequities in health care. We need to have a greater understanding of how social determinants of health affect the lives of our patients to come up with a way forward. We will be launching a series of podcasts that will address the social determinants of health, their impact on cancer care, and modifiable risk factors for cancer. The podcasts will be designed for medical trainees and fellows, as well as faculty in the early stages of their oncology career.
I’m envisioning that the content of the podcasts will initially cover general discussions of the social determinants of health, such as socioeconomic status, education, environment, and access to health care, and how to integrate those factors into taking patients’ medical history. With this information, we would have a better understanding of the barriers—financial, social, and cultural—that make it challenging for our patients to access high-quality oncology care. We plan to have a focus group of fellows and junior faculty to provide input on the content and length of these podcasts. We hope they will become an enduring educational tool.
Our overarching goal is to embed the principles of health equity into everything ASCO does to achieve high-quality care for all patients, and we want to weave these principles into all ASCO programs, so they become seamless. For example, we are planning to have aspects of health equity in most of the sessions presented during the Annual Meeting, rather than as stand-alone sessions, to reach a broader audience. We are planning to work with study presenters and discussants to ensure that health equity is included in their remarks, because these principles need to be embedded in all we do.
I am just a few months into my presidential term and have several more months to carry out these goals. There is a lot of negativity in the world right now, which could lead to further health inequities. That is why it is so important that ASCO has laid the groundwork to put multiple initiatives in place to improve our ability to deliver equitable care for all cancer patients. Everyone is working together to move this agenda forward.
It is our time.
DISCLOSURE: Dr. Pierce holds stock, intellectual property, or other ownership interests in PFS Genomics and receives royalties from UpToDate.
REFERENCES
1. Loree JM, Anand S, Dasari A, et al: Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol 5:e191870, 2019.
2. Duma N, Vera Aguilera J, Paludo J, et al: Representation of minorities and women in oncology clinical trials: Review of the past 14 years. J Oncol Pract 14:e1-e10, 2018.
3. DeSantis CE, Miller KD, Goding Sauer A, et al: Cancer statistics for African Americans, 2019. CA Cancer J Clin 69:211-233, 2019.
4. Patel MI, Lopez AM, Blackstock W, et al: Cancer disparities and health equity: A policy statement from the American Society of Clinical Oncology. J Clin Oncol. August 12, 2020 (early release online).
5. Jamison P: Anti-vaccination leaders fuel black mistrust of medical establishment as covid-19 kills people of color. The Washington Post, July 17, 2020. Available at https://www.washingtonpost.com/dc-md-va/2020/07/17/black-anti-vaccine-coronavirus-tuskegee-syphilis. Accessed August 25, 2020.
6. Pierce LJ: Responding to racism and health inequality as a cancer care community. ASCO in Action, June 3, 2020. Available at https://www.asco.org/practice-policy/policy-issues-statements/asco-in-action/responding-racism-and-health-inequality. Accessed August 25, 2020.
