Clinical Trial Diversity
Marginalized racial and ethnic groups, women, and other historically disenfranchised populations are substantially underrepresented in clinical trials, despite increasing concern about this issue among policymakers, patient advocates, and some industry leaders.
Clinical Trial Diversity
The sad truth is that, across most cancers, Black Americans have the highest death and shortest survival rates of any racial or ethnic group. To correct course, the health care community must take steps to increase representation of minority groups in clinical trials and help them take better advantage of life-saving technology and therapies.
Most clinical trials are not representative of the general population or of those with a particular disease. Clinical trials primarily enroll white, male patients, with consistent underrepresentation of women, the elderly, and people of color especially Black and Hispanic patients. While people of color make up about 39 percent of the U.S. population, these groups represent from 2 percent to 16 percent of patients in trials.
Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity.
The Disparity
Disparities in clinical trials have been a concern for decades, but it’s generated more attention as the field of precision medicine has taken off. As targeted therapies become a reality and as dozens of personalized medicines on the market help patients live longer lives we must do more to consider differences between people of varying races, ethnicities and gender.
A major contributor to this outcome disparity is the underrepresentation of African Americans in oncology clinical trials. Research shows that Black Americans, who make up roughly 14 percent of the U.S. population, account for only 3.1 percent of participants in clinical trials for cancer drugs.
This lack of proportional representation is damaging to science and limits our ability to consider potential differences — and develop effective treatments — across population subgroups. Without more minorities and women in trials, we can’t effectively determine how someone’s race, ethnicity or even gender might impact their response to a particular treatment.
Importance of Clinical Trials
A clinical trial is a type of clinical research that evaluates the effects of intervention(s), including drugs, devices, surgeries, diets, behavioral approaches, and lifestyle interventions, on health-related biomedical or behavioral outcomes.
Clinical trials can:
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Determine if a new intervention is safe, works better, and/or has fewer side effects than an existing treatment or intervention.
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Examine ways to detect a disease early, when it is potentially more treatable, or ways to prevent a health problem altogether.
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Evaluate ways to improve the quality of life of people who have an illness or chronic medical condition.
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Include testing of behavioral, social, environmental, and structural interventions.
Clinical trials are the final step in a long process that begins with research in a lab. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. They also try to figure out possible side effects.
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Clinical trials are conducted according to a plan, called a protocol, which describes:
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The types of patients who may enter the study
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The schedules of tests and procedures
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The drugs involved
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The dosages, or amount of the drug
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The length of the study
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What the researchers hope to learn from the study.
Barriers to Clinical Trial Participation
As clinical trials play a dominant role in the development of safe and effective treatments to reduce the societal burden of disease, participation by minorities and women is crucial to assure sufficient scientific information to assess the safety and efficacy of new treatments.
Common barriers include
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Distrust
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The history of abuse in the name of research has created real and well-founded fear and skepticism in the African-American community.
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Provider perceptions
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Research has shown that physicians are less likely to prescribe certain treatments to their minority patients.
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Access to care
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People of color have historically had poor access to medical care. Some studies indicate that the majority of disenfranchised minorities have access only to providers and hospitals that have limited resources
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Lack of awareness about trials
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Many patients are not even offered clinical trials that maybe available to them
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Financial barrier
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The costs of cancer treatment and medication, transportation, child care, lost work, and inadequate or complete lack of insurance
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Communication issues
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Clinical trial information may not be in the patient native language which creates additional barriers
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What is Next?
Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products.
Physicians must play an active role in this effort, by ensuring that all patients are offered appropriate clinical trial options, regardless of race/ethnicity or socioeconomics.
Intervention strategies need to address barriers across all levels from dismantling structural racism to catering to the individual needs of cancer patients.
Community outreach and patient navigation can enhance minority participation in clinical trials.
Connecting with the community and building trust are particularly important when engaging with racial and ethnic minorities who may distrust research and the health care system due to historical injustices.
There are various ways to learn about a trial you may be interested in taking part in:
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Your doctor may tell you about a trial that they think might be suitable for you.
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You may do your own research.
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You could ask a patient advocacy group.
Additional Resources
