Head and neck cancer trials 'becoming less diverse'

Despite efforts in the US to increase the diversity of clinical trials, a study has found that in one form of cancer the trend seems to be going in the other direction.

Researchers from Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center (BMC) reviewed cancer trials around the US and found that head and neck cancer studies are becoming less racially and ethnically diverse over time.

There are very good reasons for studying head and neck cancer in this way, as the disease continues to have a high mortality rate and there is a high level of inequity in outcomes between different racial groups.

The analysis by head and neck surgeon Heather Ann Edwards and medical student Melani Zuckerman looked at head and neck cancer studies listed in the clinicaltrials.gov register between 2000 and 2023 that collectively recruited nearly 9,000 subjects.

Over that period, they found that the percentage of White patients increased by 6.1%, while the Asian population decreased by 3.1%, and that the Black patient population increased by 0.8%.

In addition, compared to previously published data, the studies had "significantly more White patients, fewer Black patients, and fewer Asian/Native-Hawaiian patients" than are seen in the head and neck population at large.

The disappointing trend has come despite much-trumpeted programmes by the FDA, National Cancer Institute, and other groups to make studies more inclusive. For example, the FDA recently published new guidance demanding that study sponsors make diversity a part of their planning.

Although over 40% of the US population is currently comprised of ethnic and racial minorities, typically only 5% to 10% of clinical trial participants represent any minority population, and that could expose those who are not White to the risk that a new therapy is ineffective or potentially even harmful.

"Tragically, we live in a time when things like your race and gender impact how likely you are to survive your cancer," said Edwards.

"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," she added.

The researchers are now reviewing individual studies that have been successful in enrolling more diverse and representative patient populations to see what they are doing right, in the hope of finding alternative approaches to tackling the issue.

The study has been published in the journal Head & Neck.

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