Efforts to increase diversity in cancer clinical trials fall short

In the U.S., millions of people experience cancer every year but don't have an equal opportunity to access experimental treatments in clinical trials, or to receive treatments that were shown to be effective in patients like them. Over the past several years, there have been numerous efforts by major national organizations such as the U.S. Food and Drug Administration, the National Cancer Institute and NRG Oncology to increase opportunities for diverse communities to enroll in clinical trials to improve and ensure that new cancer treatments are being developed for the populations that will use them. 

To determine if these efforts have been successful, researchers from Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center (BMC) reviewed cancer clinical trials around the country and found, in head and neck cancer, these trials are actually becoming less racially and ethnically diverse over time. The situation of inequitable representation in cancer research has actually worsened in the last 10 years.

Tragically, we live in a time when things like your race and gender impact how likely you are to survive your cancer. Research like this is striving to overcome these inequities to provide everyone facing a cancer diagnosis with opportunities to access treatments that were shown to be effective in patients like them."

Heather Ann Edwards, MD, FACS, FRCSC, senior author, associate professor of otolaryngology-head & neck surgery, Boston University Chobanian & Avedisian School of Medicine

In order to see if clinical trials were becoming more representative over time, the researchers reviewed a repository of trials maintained by the National Institutes of Health's national library of medicine. They focused specifically on head and neck cancer, which is a cancer that continues to have a high mortality rate and has significant racial inequity in outcomes. In addition to examining the database, the researchers examined published manuscripts from the studies to collect information about the demographics of the people who participated in these clinical trials.

"We looked at how the patients enrolled in the studies changed over time, to see if racial, ethnic and gender diversity was improving over time. We were surprised to find that it was actually worsening," added Edwards who also is a head and neck surgeon and Director of the Head and Neck Surgery Program at BMC.

According to the researchers, current approaches do not appear to be resulting in meaningful improvement and new options need to be pursued. They are now reviewing individual studies which have been successful in enrolling more diverse and representative patient populations to see what they are doing right. They hope this will contribute to more effective, alternative approaches to improve this worsening problem. 

At BMC, the head and neck cancer team have created initiatives to improve access to clinical trials for patients from historically underrepresented populations. This has resulted in 58% of head and neck cancer clinical trial participants being underrepresented groups in medicine, compared to national data that suggests only 7-12% of cancer trial participants are Black or Hispanic.

"Our study highlights the continued need for greater diversity in head and neck cancer clinical trial populations. We aim to inspire clinical trial administrators and participating physicians to prioritize inclusivity, ultimately leading to treatments that improve quality of life for all head and neck cancer patients," said corresponding author Melani Zuckerman, BA, a fourth-year medical student at the school.

These findings appear online in the journal Head & Neck.