Clinical trials are essential for advancing medical knowledge and developing new cancer treatments, and a key component of these trials is the involvement of volunteers from diverse backgrounds. According to Liliana Larsson, MSN, RN, OCN, a pancreatic nurse navigator at MD Anderson Cancer Center/Sheik Ahmed Center for Pancreatic Cancer Research in Houston, this representation is crucial to ensure that clinical trial results in cancer are applicable to the entire population, not just select groups. At the recent AONN+ Annual Conference in San Antonio, TX, Ms Larsson discussed the significance of diversity in clinical trials and explained how it ultimately contributes to health equity.
“Ensuring diversity in clinical trials is not only the right thing to do, but it also makes our research stronger and our society more equal,” she said. “Navigators and social workers play a critical role in identifying and addressing these disparities and removing barriers to healthcare access.”
Diversity, as defined by the Oxford English Dictionary, refers to the state of being different or unique in nature, form, or quality. In the context of clinical trials, diversity means including participants from various genders, ethnicities, ages, social backgrounds, orientations, and a litany of other individual factors. This inclusion contributes to a comprehensive understanding of how cancer treatments work across different population groups.
“Clinical trials are essential for developing new treatments and enhancing our understanding of existing ones,” she said. “But a crucial part of this is the involvement of a diverse group of volunteers.”
Achieving health equity is directly tied to diversity in clinical trials. According to Healthy People 2030, health equity is the attainment of the highest level of health for all people; it involves creating a fair opportunity for everyone to achieve their healthiest possible life regardless of their background. When trials include diverse participants, they provide insights into how treatments affect different groups, thereby promoting equitable healthcare outcomes.
A number of barriers hinder the inclusion of diverse populations in clinical trials. They include restrictive inclusion and exclusion criteria, lack of awareness, and logistical challenges, such as transportation and financial constraints.
But a number of barriers hinder the inclusion of diverse populations in clinical trials. They include restrictive inclusion and exclusion criteria, lack of awareness, and logistical challenges, such as transportation and financial constraints.
“For navigators and social workers, we can increase diversity by raising awareness and educating every patient about clinical trials, utilizing their preferred language and also looking at their culture from their lens,” said Ms Larsson. “We can help to build trust in medical research within our institutions by advocating for patients during tumor boards and being the liaison between the clinical and research teams.”
In addition, ensuring diversity involves providing patients with resources and education about lodging, transportation, and financial assistance, she added.
The majority of these participants are White, with significantly lower representation from minority groups. This lack of diversity can skew trial results, as it does not reflect the broader population’s experience.
A review of the FDA’s Drug Trials Snapshots Summary Report reveals that the United States enrolls 35% of participants in clinical trials worldwide, the largest share among all countries. However, the majority of these participants are White, with significantly lower representation from minority groups. This lack of diversity can skew trial results, as it does not reflect the broader population’s experience.
“Individuals are going to experience disease in unique ways; diverse life experiences, living situations, and traits are going to impact how a patient reacts to certain treatments,” she said. “The impact of cancer doesn’t discriminate among population groups. So if the inclusion of minority demographics in the development of new treatments doesn’t increase, the gap in health inequities will.”
She added that diversity in trials entails more than just inclusion of different races and age groups. It also includes level of education, income, disabilities, geographic location, personal background, and much more.
The impact of underrepresentation in clinical trials is also well documented. A study published in the American Journal of Respiratory and Critical Care Medicine showed that the frontline asthma drug albuterol is less effective for African American and Puerto Rican children compared with European American and Mexican children. This discrepancy was identified through a large whole genome sequencing study, underscoring the need for diverse participation in trials.
“This is why it’s so essential that people participating in these trials mirror the eventual users of the drug or product,” she noted. “Unfortunately, the current reality falls short, and this discrepancy is worrisome.”
The COVID-19 pandemic highlighted existing health disparities, prompting legislative efforts to address these issues. One such initiative is the DEPICT (Diverse and Equitable Participation in Clinical Trials) Act, which mandates the inclusion of diversity action plans in clinical trial designs. “It’s no longer a recommendation; it’s a mandate,” she emphasized.
This act aims to ensure that late-phase clinical trials include diverse populations, making the research more inclusive and representative.
“By embracing diversity in clinical trials, we not only bridge gaps in knowledge, but we also pave the way for a more inclusive and effective healthcare system,” said Ms Larsson. “Including people from different backgrounds in clinical trials makes the research fair and trustworthy, and when we include people from all walks of life, we are making sure that everyone gets a fair chance at good health.”
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