By Krystal Redman (KR), DrPH, MHA, (they/she), Executive Director
At last year’s San Antonio Breast Cancer Symposium (SABCS), we discussed the recurring theme of panelists, scientists, researchers, and clinicians identifying race as a leading factor in health disparities among Black and Brown populations. We highlighted the lack of intentionality around diving deeper into investigating the impact of racism in comparison to race, and how this affects the environment and individuals, resulting in disproportionate breast cancer outcomes and deaths related to breast cancer incidence amongst Black, Indigenous, & People of Color (BIPOC) in comparison to white people.
In my 2021 blog entitled “Are You Really Ready To Build Trust?,” I focused on accountability in science and healthcare, the need for diversity in clinical trials, and what equitable solutions toward inclusivity would look like, in terms of steps to building trust.
This year, more panels have progressed and reached the evolutionary stage of “acknowledging the existence of inequities and accepting that solutions be patient-centered.” Great! Now what? How are research centers, healthcare systems, clinicians, and big data projects putting these principles into practice?
I attended a presentation led by Martin Mendoza, PhD from the National Institute of Health (NIH) discussing clinical trial diversity. The discussion was a part of the “Big Data and Health Equity” session and was titled: “Achieving Health Equity through the All of Us Research Program.”
This session gave me a glimpse into what researchers took away from last year’s SABCS, and have learned since, resulting in an increase in the attention to diversity and inclusion in clinical trials, as well as to the importance of patient and community engagement approaches and practices.
For instance, BCAction held a very dynamic panel during our Drawing the Connections event entitled “Trusting the Science” in April of this year, highlighting the history and current events leading to the lack of trust in science, and how medical institutions often lack patient-centered solutions to this distrust. We proposed possible solutions and reckoning, which included, but were not limited to;
So, attending Dr. Mendoza’s keynote speech and presentation was enlightening, as he discussed the importance of diversity and equity in biomedical research and the lack of inclusion of minorities. [side note: it’s past time that we stop calling nonwhite, diverse ethnic and racial groups “minorities,” minority meaning “the smaller number or part,” when in fact, it is common knowledge that BIPOC and POC make up the majority in our country. If the intention is to say BIPOC groups, POC groups, or marginalized communities–then science needs to get comfortable in saying just that].
During this session, Dr. Mendoza verbalized that “minority” predominantly meant Black and brown communities.* He highlighted that, minorities* make up the statistical majority of the US population, further that Black Americans are the second largest minority group in the US, but only make up 6.7% of National Institute of Health (NIH)’s clinical population nationwide. He notes that research needs to take into account the unique biological, medical, and social factors of minority groups, especially given that the majority of clinical trial’s participants are white patients. Dr. Mendoza further notes that there is a lack of diversity in genome-wide association studies–and it’s not clear what the Food and Drug Administration (FDA) is doing about this.
NIH’s All of Us research program is part of the broader Precision Medicine Initiative, through the National Institute of Health. One of the aims of the program is to recruit 1 million participants into a diverse health database, one that would reflect diversity in the US. Dr. Mendoza mentions that the program will focus on elements of “lifestyle and environmental data.”
The mention of “lifestyle data” was presented vaguely. My concern is that any emphasis on lifestyle may be disproportionately focusing on individual causes of breast cancer (e.g., smoking, dietary, and physical activity choices, etc.). Breast cancer advocates know that this disease does not exist in a vacuum, isolated away from environmental and systemic factors. With open ears, I continued to listen.
The keynote further exclaimed that the All of Us program engages people and communities left out of medical research, and places an emphasis on communities that bear a disproportionate burden of the disease.
This seems to be a well-intended program. And, in thinking about the gaps in science that BCAction highlighted from last year’s SABCS around trust and accountability, I began to focus on the HOW? How do big data agencies plan on engaging communities, building relationships? And reckoning with broken trust? To my surprise, right as I began to ask these questions, the keynote speaker began to name the “methods.”
The highlighted methods for engaging underrepresented communities in biomedical research include grassroots community engagement, which is foundational to engagement in the program; outreach, with a goal to achieve engagement, recruitment, and retention; focusing on people, geography, health status, data type; and taking a transformational approach to data access.
Dr. Mendoza went into some more detail regarding these methods:
The program has 100 strong community partnerships, including faith-based communities and community organizations, and a traveling mobile exhibit, which can help to reach the disability community and many other communities. It’s important to meet people who may otherwise not have access to the program where they are. The program also engages participants as partners– the participants serve on committees and advisory panels as “Participant Ambassadors.”
As an organization that attends SABCS every year with a patient advocate’s lens, and the goal of making information, science, data, and research accessible to our communities, as well as keeping breast cancer researchers, doctors, and scientists accountable to the people they aim to benefit–I was excited to hear that more time and attention is going towards creating a program with a focus on recruiting patients with underrepresented identities, but I was still left with the question of “how?” and “when?”
How will big data agencies apply their “methods” and when will they begin putting principles into practice? Yes, creating a program that focuses on community engagement and grassroots methods is great. Developing relationships with community partners is also great. But what about reckoning with the distrust of science and similar programs more generally? How are big data and the healthcare system naming and addressing not only the historic and current reasons why BIPOC people are extremely hesitant to participate in trials, but also the lack of accessibility to clinical trials? It’s not enough to understand that there is a lack of trust between BIPOC patients and science, but what is being done about it? How are big data agencies proposing to assure the comfort and safety of marginalized patients, so that harm is not perpetuated?
Further, have clinician-related barriers to ensuring racial and ethnic diversity in clinical trials been addressed? These can include physician biases, limited or lack of capacity, time and resources, knowledge of clinical trials, and physician communication to patients.
And, have patient-related barriers to racial and ethnic diversity in clinical trials been addressed? These barriers may include availability of trials, distrust, diverse social and environmental inequities and disparities, language barriers, cultural barriers, lack of information about trials, lack of understanding and literacy around trials. The list of questions goes on. How do we achieve quality in care and medical trust? How do we increase clinical care in trials? How do we build trust and engage patients as we navigate this stage?
Big data agencies building relationships with grassroots community partners sounds good, but just because you build relationships with community partners does not automatically mean that people (patients) will trust the big data agencies enough to engage in clinical trials.
All in all, as a patient advocate, it is good to hear that big data agencies are increasingly attempting to focus more on clinical trial inclusiveness. And, building trust and creating equity in health requires more than just taking a “look at inequities in clinical trials;” you also have to be transparent, take accountability, and be intentional about applying methods for dismantling barriers to true access to equitable care–including trials.