Improving Cancer Care for All: The Case for Representation in Clinical Trials
A critical disparity persists in cancer care: racial and ethnic minorities remain significantly underrepresented in clinical trials despite often facing higher cancer incidence rates and worse outcomes. As a result, the very communities most in need of innovative cancer treatments risk being left behind in the rapidly advancing oncology field.
Moffitt recognizes the urgent need to address this need for more diversity in clinical trials. We know that health equity can only be achieved when our research encompasses the full spectrum of our patient population. That's why we're committed to breaking down the barriers that hinder participation, actively working to improve access and engagement for a more diverse community of patients.
Disparities and Barriers
Although racial and ethnic minorities makeup over 40% of the U.S. population and often have higher rates of certain kinds of cancer, they represent only 2-9%, a small fraction, of clinical trial participants. Demographic representation in Phase 1 biopharmaceutical oncology clinical trials in the U.S. is heavily skewed toward White/Caucasians (84.2%), with minimal inclusion of Black/African-Americans (7.3%), Asians (3.4%), and Hispanic/Latinos (2.8%).
“This translates to the results from clinical trials not being fully generalizable to the overall population,” said Yayi Zhao, Moffitt Cancer Center research data analyst. Zhao urges that more diversity in clinical trials will allow a broader audience to benefit from the research.
Several barriers prevent minorities from enrolling. A lack of awareness of trials and candidacy, limited access to this kind of care, and a mistrust of the medical system all contribute to minority hesitancy to participate in clinical studies. Patient Allison Edgecomb credits her Moffitt care team with explaining the benefits and the process clearly, which ultimately made her feel comfortable enough to enroll in a clinical trial for HER2-positive breast cancer.
Another subtype of breast cancer, triple-negative breast cancer (TNBC), is one of the many specific cancers that disproportionately affect Black individuals. Black women are twice as likely as white women to be diagnosed with TNBC than white women, yet their participation in relevant trials is as low as 2-3%. These specific cancer disparities in trials create gaps in research and data that could otherwise support the care of the groups most likely to be affected by the diseases.
Disparities also exist in the research that leads to drug approvals. A 2021 study found that for 81 chemotherapy drugs approved by the FDA between 2009 and 2019, only 2.5% of their clinical trial participants were Black, and 2.3% were Hispanic.
These disparities highlight the need to address mistrust in the healthcare system, limited access to trial locations, eligibility criteria that inadvertently exclude minorities, and insufficient outreach and communication with diverse communities. By overcoming these challenges to create equitable access to clinical research opportunities, we can develop more effective cancer therapies across all populations and move closer to achieving cancer health equity.
To achieve improved clinical trial diversity, community physicians must actively discuss appropriate clinical trial options and refer patients to clinical trial programs like Moffitt, regardless of patient race, ethnicity, or socioeconomic status. Study design must also be carefully considered to ensure a diverse trial workforce, culturally tailored education materials, and minimized trial participation costs.
Furthering our understanding of the possible challenges our patients face is critical in providing quality and empathic care. In 2022 Moffitt Cancer Center, Orlando Health and United Way of Broward County launched the Health Equity Train-the-Trainer program to improve health equity across the state. All three organizations are partnering with support from a combined $2.5 million health equity grant awarded by the Florida Blue Foundation, the philanthropic foundation of the state’s Blue Cross Blue Shield plan.
Dr. Desiree Chachula
The program curriculum was developed by Dr. Desiree Chachula and members of the Enterprise Equity Team and educates health care professionals on health equity issues and includes topics such as, health disparities, bias and stereotyping, community strategies, cross-cultural communication, equity in communication, and implementing changes for health equity.
Improving Participation - Moffitt’s Commitment to Diversity
Moffitt is committed to improving minority participation in clinical trials to ensure research is representative of the populations it affects and create better outcomes for all.
1. Community Outreach and Engagement
We believe that improved trial participation begins on the ground, in the heart of the communities we serve. Moffitt’s Office of Community Outreach and Engagement (COEE) was created to prioritize health equity, maximize the impact of research, and ensure a continuous bi-directional exchange of information between researchers and the local population.
Dr. Kedar Kirtane
Our specific efforts to increase minority participation in trials are led by Dr. Kedar Kirtane, who oversees the Reaching and Engaging Special Populations to Expand Clinical Trials (RESPECT) committee. The committee aims to build enhanced trust, address patient barriers, and engage community healthcare providers to refer eligible patients so they can accurately reflect Moffitt’s catchment area and beyond.
2. Improving Trial Accessibility
Moffitt is actively developing digital tools to improve trial accessibility. In collaboration with the Biostatistics and Bioinformatics Shared Resource (BBSR) at Moffitt, the ACTWONDER2S study is refining six tools. The tools have a range of goals, from improving trial participation decision-making and streamlining referrals to identifying gaps contributing to enrollment disparities.
3. Building Trust
Another barrier we’re striving to address is mistrust in the healthcare system and the cancer care field specifically. One way we strengthen community trust is by dispelling pervasive myths about clinical trials that might prevent eligible patients from participating, like fear of receiving a placebo effect that would stall treatment, the mistaken belief that trials are for patients without other options, and the perception of a lack of protection of patient rights and welfare.
“Trust has been a major issue within the Black community when it comes to health. There are people in our community who don’t trust doctors, the health care system, or the government either because they had a bad experience or a family member had a bad experience, said Dr. B. Lee Green, a senior member in Moffitt’s Department of Health Outcomes and Behavior. “It’s difficult to pinpoint just one or two things that cause disparities, and there are no one-size-fits-all solutions. But we must innovate, and we have to identify those disparities in order to address equity.”
4. Enhancing Diversity in Research Teams
Diversity, equity, and inclusion are cornerstones in Moffitt’s mission, and it starts with our leadership. In 2023, Moffitt created our Office of Research Diversity & Workforce Development to increase diversity in teams so we’re capable of more impactful research. This includes diversity across the research workforce in race and ethnicity, gender, disability, and background to ensure that our internal environment looks like the community we serve. Through this office and our Diversity Department, we aim to set a new national standard for research teams in terms of representation that embraces and celebrates differences.
Dr. Tiffany Carson
Additionally, Moffitt is participating in international research to tackle cancer inequities. Moffitt’s Dr. Tiffany Carson is part of the Societal, Ancestry, Molecular, and Biological Analyses of Inequalities (SAMBAI) team, which recently won a Cancer Grand Challenges award. This award provides an investment to fund the development of novel approaches to addressing existing cancer disparities.
Through this work to enhance diversity in research teams, we can already see a change in tone in the community—minorities are increasingly viewing Moffitt as a helpful resource to help them.
5. Data Collecting and Tracking
Effective data collection and tracking are essential for identifying and overcoming disparities, as we can only address issues and barriers we know about. One study led by Moffitt Cancer Center’s Department of Breast Oncology, revealed key information about patient attitudes and reservations toward clinical trials, which allows us to use this real-world data and integrate it into a comprehensive framework to increase the enrollment of minority participants.
Open Trials and Opportunities
Moffitt currently has several open trials and opportunities focused on improving the participation and outcomes of minority cancer patients.
Phase II of Clinical Trial 22086 is currently enrolling patients with relapsed or refractory multiple myeloma, which is two to three times more likely to affect Black people than White people and twice as deadly for them.
Dr. Brandon Blue
To overcome this obstacle, Dr. Brandon Blue has a strategy to fight multiple myeloma before it becomes cancer. The Promise Study provides free screenings for Black people over 30 or for anyone with a close family member who has multiple myeloma or one of its precursor conditions. By detecting and treating people with Monoclonal Gammopathy of Undetermined Significance (MGUS) and other precursor conditions, we can delay or prevent some of the serious complications that can occur with multiple myeloma.
Final Thoughts
At Moffitt Cancer Center, our commitment to improving minority participation in clinical trials is fundamental to our mission of advancing cancer care for all. By fostering community collaboration, increasing internal diversity, and meticulously researching and addressing minority barriers, we're working to ensure that our research truly represents and benefits the diverse communities we serve.
However, we can't do this alone. The support and involvement of our community, including referring providers, are crucial to our success. By working together, we can ensure that clinical trials are accessible to all eligible patients and that the benefits of cancer research are shared equitably across our diverse population.
If you would like to refer a patient to Moffitt, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.