Many patients with head and neck cancer may lack equal opportunity to access experimental treatments in clinical trials or receive treatments that were shown to be effective in similar patients, according to a recent study published by Zuckerman and Edwards in Head & Neck.
Background
Millions of patients experience cancer each year in the United States. Over the past several years, there have been numerous efforts made by major national organizations such as the U.S. Food and Drug Administration, the National Cancer Institute, and NRG Oncology to increase enrollment in cancer clinical trials among diverse patient communities—with the goal of improving novel cancer therapies and ensuring that these treatments are being developed for populations that will use them.
Head and neck cancer continues to have a high mortality rate and significant racial inequity in outcomes. National data have indicated that just 7% to 12% of cancer trial participants are Black or Hispanic.
“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,” explained senior study author Heather Ann Edwards, MD, FACS, FRCSC, Associate Professor of Otolaryngology–Head & Neck Surgery at the Boston University Chobanian & Avedisian School of Medicine as well as Director of the Head and Neck Surgery Program and a head and neck surgeon at the Boston Medical Center.
Study Methods and Results
To determine whether these efforts have been successful, investigators conducted a retrospective analysis of clinical trials data from ClinicalTrials.gov, focusing specifically on head and neck cancer. In addition, the investigators examined published manuscripts from the studies to collect information about the clinical trial participants’ demographics.
The investigators found that head and neck cancer trials became less racially and ethnically diverse over the study period. Despite efforts to overcome inequities in cancer clinical trials, they stressed that inequitable representation in cancer research may have worsened over the past 10 years.
“We looked at how the patients enrolled in the studies changed … to see if racial, ethnic, and gender diversity was improving over time. We were surprised to find that it was actually worsening,” stressed Dr. Edwards.
Conclusions
The findings suggested that current approaches did not lead to meaningful improvement. As a result, new strategies may need to be developed to address inequities in cancer clinical trials.
The investigators are currently reviewing individual studies that have been successful in enrolling more diverse and representative patient populations in order to identify effective, alternative approaches to improve worsening inequities.
“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,” concluded lead study author Melani Zuckerman, BA, a fourth-year medical student at the Boston University Chobanian & Avedisian School of Medicine.
Disclosure: For full disclosures of the study authors, visit onlinelibrary.wiley.com.
