By Sara Bondell - June 06, 2021
When Stella Dellinger was diagnosed with breast cancer in 2010, she was filled with an overwhelming fear of the unknown. After a double mastectomy and chemotherapy, that dread struck again when her doctor said two words she had never heard before: clinical trial.
A clinical trial is a research study that tests how safe and effective a treatment is prior to federal approval. A native of Colombia, Dellinger says until that moment, she had no idea what a trial was.
“We are not educated about those things, that is the truth,” said Dellinger. “I was so scared because you don’t know anything about it and you don’t have anyone else to talk to who is in the same position.”
Dellinger is not alone. Whether it is due to a lack of awareness or distrust of the medical community, minority patients are underrepresented in clinical trials. According to the Sidney Kimmel Comprehensive Cancer Center, less than 10% of cancer patients enrolled in clinical trials are racial or ethnic minorities. Between 2016 and 2018, 5.4% of Black patients and 8.7% of Hispanic patients were enrolled in any trials at Moffitt Cancer Center.
The lack of diversity in clinical trials can result in minority populations missing out on receiving treatment at early stages of disease or losing complete access to potentially life-saving treatment. So, Moffitt has made it a priority to identify ways to break down barriers and increase access to care for minority patients.
When researchers stopped just looking at cancer under the microscope and started analyzing the genetic makeup of a tumor, everything changed. They realized each patient is an individual, and that your genes can impact your cancer and treatment response. Race and ethnicity play a key role in your genetic makeup.
“If your clinical trial predominately enrolls white men, then the data that you obtain from the trial may not be as informative regarding how the treatment will perform in let’s say females or minority populations,” said Hatem Soliman, MD, medical director of the Clinical Trials Office at Moffitt.
While Blacks have the highest death rate and shortest survival rate of any group in the United States for most cancers, ProPublica found that in trials for 24 out of the 31 cancer drugs approved in the past three years, less than 5% of the participants were Black.
“If we don’t accrue diverse populations to trials the results are in turn less diverse,” said Jhanelle Gray, MD, chair of Moffitt’s Department of Thoracic Oncology. “Yet we take results and apply them across multiple diverse groups. This is a knowledge gap we need to overcome.”
To overcome the challenge, multiple barriers need to be broken down that contribute to health care disparities. For some, there are socioeconomic issues like transportation, childcare and lack of access to affordable insurance. For others, it’s mistrust that is deeply rooted in the nation’s history.
In 1932, the Public Health Service and the Tuskegee Institute launched a study to track the progression of syphilis in Black men. The study involved 600 Black men who were told they were being treated for “bad blood,” a term used to describe several different ailments. Not only had the men been misled and not given all the facts required to provide informed consent, but the men were also never given adequate treatment for their disease. Because of this, many died, went blind or experienced other severe health problems. The study was stopped in 1972 after an advisory panel concluded it was ethnically unjustified.
“This has been difficult to overcome because you have the legacy of these historical events,” said Soliman. “Minority patients still express distrust of medical establishments in some cases. You hear the phrase, ‘We don’t want to be used as guinea pigs.’”
The idea of fatalism can also be found in some minority communities. When someone is diagnosed with cancer, they can have the idea that things are in a higher power’s hands, and that despite medical intervention, whatever is going to happen will happen. It can be a powerful notion that keeps patients from enrolling in clinical trials.
“I think understanding all of these sensitivities and nuances when you’re talking to patients is going to be critical to breaking down these barriers,” said Gray.
Because there are multiple factors that cause health care disparities, there needs to be a multi-factorial approach to fighting it. Moffitt’s main goal is to identify the differences in health care delivery to minority populations and establish new ways to provide better outreach to those communities.
To help with that task, Moffitt created the Office of Community Outreach, Engagement and Equity in 2018. The office works to keep equity at the forefront of the cancer center’s research and sends outreach team members into the community to increase awareness on topics like screening and clinical trials.
“With the diverse communities that we serve, there is not a one-size-fits all-model and having people who reflect and understand the different groups that make up our diverse community builds respect and trust on both sides,” said Susan Vadaparampil, PhD, MPH, associate center director of the Office of Community Outreach, Engagement and Equity. This doesn’t just apply to race and ethnicity, but also to gender and age, HIV-positive patients and sexual and gender minorities.
When Trials and Navigation Educator Viviam Sifontes began doing outreach work in the Hispanic community, she saw firsthand the negative attitude toward trials and the immediate need for education. “There are cultural and historical barriers that exist that are very rooted into people’s minds and hearts in the Hispanic community,” she said. ““I want them to know we’re not playing with human life.”
"There are cultural and historical barriers that exist that are very rooted into people’s minds and hearts in the Hispanic community. I want them to know we’re not playing with human life."- Viviam Sifontes, Trials and Navigation Educator
So, Sifontes started chipping away, one presentation, one patient at a time. She explains what a clinical trial is, dispels misconceptions and highlights medical regulations that promote accountability and transparency. She also relies on her own experiences to make connections (she is a cancer survivor and has been enrolled on a clinical trial). This made all the difference for Dellinger when she met Sifontes at Latinas United for a New Beginning (LUNA), a support group for Hispanic breast cancer patients and survivors.
“Within minutes of meeting Viviam, we had an immediate connection,” said Dellinger. “That connection is so important. She was someone who got to know me and guided me, which is what I needed because I was blind. I was just taking the word of the doctors, but now I had someone else who has gone through what I have.”
Sifontes says while recruitment is always challenging, things are slowly improving. “Now that we are doing personalized medicine I think people are more prone to listen and realize, okay, they are making a medication specifically for me. That opens the window of opportunity so hopefully we will see an increase in minority recruitment.”
Moffitt has also launched the RESPECT, or Reaching Out and Engaging Special Populations to Expand Clinical Trials, program. It focuses on bringing together providers, researchers, clinical trial coordinators and social workers to ensure every patient is educated about clinical trials and is offered an opportunity to enroll if possible.
The Thoracic Oncology Program has taken it upon itself to dig even deeper into building awareness thanks to TIDE, or Thoracic Honors Inclusion, Diversity and Equity. “It’s to help us all know that we have implicit bias and learn how to recognize it, deconstruct it within ourselves and make sure we don’t carry it to our colleagues, to the clinic, to our research or to our patients,” said Gray. The clinic also has established the Thoracic Minority Accrual Task Force that continually investigates patient accrual and brainstorms ways to partner on health care disparity initiatives and increase the diversity in clinical trials.
Moffitt’s Research Institute not only has a Minority Clinical Trials Committee, but has also tasked researchers with analyzing the center’s last 10 years of work in health care disparities to better identify key areas that need new strategies and resources. The institute has also created an initiative to fund internal clinical trials geared specifically toward addressing the unmet needs of minority populations. It has led to groundbreaking research in both solid and liquid tumors, such as ways to optimize the mismatched bone marrow transplants that minority patients usually undergo.
“I think things are moving faster than they were 10 years ago,” said Gray. “I think the recent social unrest has brought a lot to light and really helped with the dialogue and understanding of where some of the disparities and discourse come from. The importance of focusing on this has become a little more tangible, visible and elevated.”
Dellinger is continuing to fight her cancer, and has been enrolled on multiple clinical trials over the last decade. Although she has moved out of the Tampa Bay area, she continues her work with LUNA and helps educate other Hispanic women about trials.
“When new members come into our group, we try and teach them about trials and find someone to talk to them who has been through a similar experience,” said Dellinger. “But more work needs to be done to educate minority communities.”
While some inroads have been made, clinicians and researchers agree there is a lot of work left to do to increase diversity in clinical trials. It has become a top priority, but Moffitt isn’t starting from scratch.
“The good thing about Moffitt is that we started paying attention to this issue well over a decade ago and have been slowly building,” said Vadaparampil. “I think we are ahead of the game because we’ve been in the business of engaging our community from very early on.”
Moving forward, clinics pledge to be more vigilant about clinical trials to find appropriate ones for as many patients as possible. That means focusing on the patient’s unique needs, improving communication and continuing community outreach.
“I know we want to see big percentage increases in recruitment, but I feel like if we educate one person at a time, recruit one person at a time, that makes a difference,” said Sifontes. “That one makes you get up the next day and do it again.”
Behind the scenes, researchers are currently working on developing a matching software so patients don’t fall through the cracks.
No matter what the strategies are, the most important thing moving forward is sustainability.
“It can’t just be jumping on the bandwagon,” said Gray. “It has to be a cultural change. I believe at Moffitt we can collectively drive intentional change and meaningful advancements that are seen in our actions today and in the future.”