ACORI Research Review: June 2022

2022-2023 ACCC President’s Theme

Welcome back to the ACCC Research Review newsletter, re-launching after a hiatus since March of 2021. This newsletter highlights ACCC’s Community Oncology Research Institute’s (ACORI) advocacy for clinical research in the community. ACORI was established to reach equitable cancer care for all patients by closing the gaps in cancer research through knowledge, commitment, and partnership. Access to clinical trials is fundamental to quality and equitability of cancer care.

In March 2022, David R. Penberthy, MD, MBA, was named president of ACCC. Dr. Penberthy’s and his vision for the upcoming year revolves around leveraging technology to transform cancer care delivery and the patient experience. ACCC will focus on strategies that use digital health tools to increase efficiency across all aspects of oncology care, that advance equitable access to technology innovations and adequate reimbursement, and that assemble technology-driven change makers to create solutions. Digital technology will enable virtual clinical trials, improving access to cutting-edge treatment and reducing health disparities in research.

ACORI Call to Action Summit

In September 2021, ACCC and Stand Up to Cancer hosted the ACORI Call to Action Summit: Activating Equity in Community Oncology Research, which included oncology clinicians, research team members, trial sponsors, industry representatives, regulatory agencies, and patient advocates. The focus of the Summit was to greatly improve diversity in clinical trials through strategies that enhance oncology research across the United States through patient and community engagement. Summit participants determined specific Calls to Action for the various stakeholders. The main action items for ACCC include ensuring that patient experiences and perspectives are embedded in all phases of research; strengthening connections between oncology programs and relevant stakeholders; engaging all stakeholders on the importance of patient and community involvement in research; implementing resources that oncology programs can use to incorporate the patient and community perspectives into their work; and advocating for diversity and representation in clinical trials.

ACCC’s Progress

To strengthen connections between among oncology programs and practices and relevant stakeholder organizations, ACCC launched the new ACORI Community on the ACCC eXchange digital platform, facilitating the sharing of effective practices and creating a platform for collaboration. This newsletter will share these effective research practices to our broader ACCC community and facilitate connections between programs with varying histories of research experience. In addition to connecting individual research sites, ACCC will bring stakeholders of all types together through this online platform that connects oncology programs and practices with larger academic centers, community partners, and industry partners. To develop and actively share information and resources, ACCC will be hosting an ACORI podcast series that highlights scalable best practices, resources, and innovative clinical research initiatives relevant to community oncology programs. ACCC also plans to create a “Community Oncology Research Blueprint” to guide cancer programs and practices on how to get started with research. This tool will include guidance and resources to support capacity across the clinical research continuum and will provide resources such as sample business plans, advisory board membership guidelines, strategies for ensuring equitable access to clinical trials, and checklists and technological tools. ACCC will also share guidelines related to hiring a diverse research workforce and training staff on health equity, community engagement, and the importance of establishing research as a standard of care.

To advocate for more diversity and representation in clinical trials consistent with the burden of cancer, ACCC will continue to communicate to state and federal governments the importance of funding community oncology research and reducing barriers for equitable access to trials. ACCC’s broad membership and deep professional networks brings clinical and non-clinical stakeholders together to improve cancer care across the country, including through clinical trials expansion. One example of this type of collaboration is the partnership between the American Society of Clinical Oncology (ASCO) and ACCC that launched in 2020 to increase racial and ethnic diversity in clinical trials. ACCC is pleased to work with ASCO to share an online implicit bias training program and a needs assessment tool developed during this multi-year initiative.

This bimonthly newsletter will continue to address ACCC’s progress in delivering results on our Summit action items. You can also expect articles and resources related to clinical trial diversification and community engagement in oncology research. And since engagement is a two-way street, please share how your cancer program or practice is advancing clinical trials, resources and references you find valuable, and any questions you have. Your direct ACORI contact is Vicki Zwicker at vzwicker@accc-cancer.org.

Thank you for your interest and thank you for taking the time to read our ACORI newsletter.

In honor of Black History month, the FDA Oncology Center of Excellence (OCE) presented a virtual panel discussion in February about building trust in clinical trials within the community. The distinguished panel consisted of two medical oncologists (Dr. Lola Fashoyin-Aje and Dr. Hala Borno), a cancer center director (Dr. Robert Winn), a breast cancer survivor and current community ambassador (Bennette Hooker), a lawyer, cancer center board member, and breast cancer survivor (Rudene Haynes), a San Francisco-based health ministry leader and past clinical trial patient and coordinator (Wilma Batiste), and the current director of the FDA’s OCE (Dr. Richard Pazdur).

Though the panel highlighted Black History month, the conversation emphasized the importance of recognizing disparities in all communities. Dr. Winn pointed out that the overarching goal in cancer treatment should be “one team, one fight,” indicating that we are all in this together and that our approach should be to support one another to fight these diseases. Addressing inequities in one community is not meant to promote one group over another: rather, when we address barriers in one group, all groups benefit.

An essential theme of the discussion revolved around improving clinical trial participation among historically under-represented patient populations. Project Equity, a public health initiative by the OCE, focuses on ensuring that experimental treatments are studied in patients who have the disease. It is well known that certain races and ethnicities have a higher risk of developing certain cancers (i.e., Black men and prostate cancer), but if those races and ethnicities are not adequately represented in the clinical trials designed to treat those cancers, then the trial results will not paint a complete picture of the tolerability and efficacy of the treatments. In other words, if certain groups of patients do not participate in clinical trials, then the treatments cannot be tailored appropriately to those patients. Increasing diversity in trials is critical to ensuring that treatment interventions will be better able to help all groups of people.

Not only is expanding trial access a matter of obtaining data from the most pertinent groups of patients, but it also provides under-represented individuals access to potentially life-changing therapies. A long-standing myth in the Black community is the belief that participation in clinical trials means being a “guinea pig.” Likewise, many patients are under the impression that randomization to a non-experimental arm in a trial means that they are receiving a placebo drug. Overcoming these barriers will require clinicians and community ambassadors to educate patients that the non-experimental arm is the standard of care treatment that they would typically receive and not an inferior treatment.

An important aspect of designing inclusive trials is to carefully consider eligibility criteria that will not be too restrictive so as to limit under-represented patients who may want to participate. Traditionally, trials have often been designed to exclude patients with certain comorbidities, but in the real-world setting, many patients who may eventually receive the newly-approved treatments are likely to have multiple comorbidities that may or may not be represented in the trials. In such cases, clinicians are then faced with using medications in patients who are sicker than those in the trials, resulting in unpredictable toxicities. Scientists, clinicians, and trial designers should construct clinical trials in a way that studies the treatments in patients who are most likely to use those treatments once they are approved.

Practically speaking, this also means designing trials with logistics that are easy for the intended patients to adhere to. Trial designers should consider the types of patients they are trying to recruit, for example: people who have full-time jobs who cannot necessarily move out of town to undergo treatment or people who may have young children or other family responsibilities that hinder them from getting frequent labs or taking inconveniently-dosed medications. These are select examples mentioned throughout the program, with the underlying idea being that trial designs need to change to incorporate more diversity into research.

When it comes to recruiting for clinical trials, Dr. Borno discussed the significance of using technology to help overcome implicit bias. Early in the treatment of HER2-positive breast cancers, there were cases of Herceptin not being consistently offered to Black women because some providers thought that these patients might not be compliant with routine treatment every 3 weeks for up to 1 year. Additionally, studies revealed some of the following biases that oncologists harbor regarding patient recruitment: “Is the patient asking the right questions? Do they seem like they’re going to be adherent? Am I going to be able to get through the consent process quickly?”

Although these types of considerations may not be maliciously intended, they are preconceived notions or assumptions that inherently separate one group of people from another, resulting in inferior treatment and thereby inferior outcomes. Providers may not be aware of many biases that could be driving inequity. Technology can help steer clinicians away from defaulting to their implicit biases by presenting all opportunities to a patient based on their clinical status rather than other factors. At the University of California San Francisco, Dr. Borno’s team created a clinical trial matching tool, called the “Trial Library,” that rapidly determines which trials a patient may be eligible for, with the goal of increasing trial recruitment of consistently under-represented patients. The reality of the situation is that gaps in care will continue to exist if we default to our biases, so we should embrace the tools that broaden our practice and perspective.

Ultimately, education is at the core of closing gaps in care in clinical trials and healthcare overall. Education to providers will break biases and improve access to care by informing of the latest trials available. Clinicians are the gatekeepers of trials, and it is critical that clinicians are informed of all the possibilities for their patients. Better outcomes start with our clinicians and what they can offer to patients.

Education to patients, caregivers, and communities will dispel myths, increase awareness of health conditions, and empower individuals to take an active role in their care. Dr. Pazdur pointed out that the polarizing media portrayal of news has led to a lot of mistrust around medical information in recent years. One strategy to combat the mistrust in the community is to host conversations addressing misinformation, such as “Facts and Faith Friday,” which is a recurring talk hosted by Dr. Winn and the local Black church community. These talks started during the COVID-19 pandemic and continue to provide an opportunity for locals to hear accurate information from trusted sources. In San Francisco, Wilma Batiste is involved in organizing health symposiums and fairs where people can get free health screenings and talk to prior clinical trial participants. The more that patients are aware of clinical trials, the better they can advocate for themselves. To quote Dr. Pazdur on encouraging participation in clinical trials, “Do it for yourself and do it for others”. We all have a role in optimizing clinical trial diversification and closing the gaps in care.

The second annual National Black Family Cancer Awareness Week is June 16-22. The OCE Project Community started this initiative last year to promote cancer awareness among Black Americans, with a focus on increasing clinical trial participation and donations to national genomic databases for cancer research.

Compared to other racial groups, Black Americans experience the highest death rate and shortest survival for most cancers in the U.S.1 Black men are 75% more likely to be diagnosed with prostate cancer than White men and more than twice as likely to die from it.2 The incidence rates of breast cancer are similar among Black and White women, but Black women have a 40% higher death rate from the disease. This disparity is even more pronounced in younger women, with young Black women experiencing double the mortality rate compared to young White women.3 Black women are also more likely to be diagnosed with aggressive subtypes of breast cancer and at more advanced stages.

These disparities, among others, highlight the strong need for better cancer care for Black Americans. Many of the disparities in outcomes can be traced to a lack of representation of Black patients in cancer clinical trials. Education is a critical component of increasing awareness and engagement in the community, by way of cancer screening programs, community health fairs, cancer walks, and other programs. The goal of Black Family Cancer Awareness Week is to stimulate conversations among family members and within communities about cancer history, cancer risk, and clinical trial participation. There is a strong social media component of this initiative, and Project Community encourages participants to use the hashtag #BlackFamCan to draw attention to the initiative.

ACORI supports this outreach by focusing on improving diversity, equity, and inclusion in clinical trials. ACORI will incorporate diverse patient perspectives in its ongoing work, collaborate with advocacy groups to develop culturally-relevant educational materials to engage under-represented communities in trials, and provide guidance for oncology programs to address social determinants of health barriers. For more information, refer to the ACCC blog on raising awareness for National Black Family Cancer Awareness Week.

References:

1. Cancer Disparities in the Black Community. American Cancer Society. Updated 2022. Accessed April 26, 2022. cancer.org/about-us/what-we-do/health-equity/cancer-disparities-in-the-black-community.html
2. African Americans and Prostate Cancer. ZERO: The End of Prostate Cancer. Updated 2022. Accessed April 26, 2022. zerocancer.org/learn/about-prostate-cancer/risks/african-americans-prostate-cancer
3. Black Women and Breast Cancer: Why Disparities Exist and How to End Them. Updated January 25, 2022. Accessed April 26, 2022. bcrf.org/blog/black-women-and-breast-cancer-why-disparities-persist-and-how-end-them.