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How often are race and ethnicity reported and represented in head and neck cancer clinical trials, and what is the generalizability of trial results given the demographics described by Surveillance, Epidemiology, and End Results Program cancer registries?
In this systematic review of 155 studies from 2010 to 2020, only 89 (57%) studies reported race or ethnicity. When compared with data in the Surveillance, Epidemiology, and End Results Program registries, clinical trials enrolled fewer Black (10% vs 8%) and Asian or Pacific Islander (6% vs 2%) participants with head and neck cancer.
Efforts must be made to increase the representation of all people in future head and neck cancer clinical trials to improve generalizability of the results and reduce racial health disparities in patients with head and neck cancers.
There is substantial evidence demonstrating racial disparities in the survival outcomes of patients with head and neck cancer. The reporting and representation of race and ethnicity in cancer trials is crucial for generalizability of trial results to patient care and reduction of racial health disparities in head and neck cancers. Racial disparities in oncologic outcomes across various therapeutic interventions may only manifest when diverse races are appropriately represented in trials.
To characterize the reporting and representation of race and ethnicity in head and neck cancer clinical trials.
A systematic search of published trials and those available on ClinicalTrials.gov was conducted to identify 3973 studies from 2010 to 2020. Title, abstract, and full-text review yielded 155 trials for data extraction of patient demographics. Year of publication, type of intervention, publication source, and funding source were also collected. Race and ethnicity data were compared with Surveillance, Epidemiology, and End Results (SEER) Program cancer registry data.
Of the 155 included studies, only 89 (57%) reported race or ethnicity. Only 81 (52%) of the studies reported detailed classification of race or ethnicity per the US Census Bureau classification scheme. Race and ethnicity reporting varied considerably with year of publication, type of intervention, data source, and funding source. Studies in the latter half of the decade were more likely to report race or ethnicity (odds ratio, 2.78; 95% CI, 1.33-5.80), with the highest number in 2019 (24 of 30 [80%] trials), followed by 2020 (20 of 29 [69%] trials). Among the possible interventions, trials on therapeutic chemoradiation most frequently reported race or ethnicity (11 of 12 [92%]), followed by supportive drug trials (22 of 31 [71%]), and then therapeutic chemotherapy trials (28 of 48 [58%]). When compared with SEER data, race and ethnicity distribution in clinical trials showed fewer Black patients (10% vs 8%) and Asian or Pacific Islander patients (6% vs 2%).
Conclusions and Relevance
In this systematic review, nearly half of head and neck cancer trials in the past decade did not report the race or ethnicity of participants. Participation of Black and Asian or Pacific Islander patients does not adequately reflect the US population’s head and neck cancer demographics, limiting the generalizability of trial results and adding to racial health disparities in patients with head and neck cancers.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: April 9, 2022.
Published Online: June 2, 2022. doi:10.1001/jamaoto.2022.1028
Corresponding Author: Linda X. Yin, MD, Department of Otolaryngology–Head and Neck Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55902 (firstname.lastname@example.org).
Author Contributions: Drs Van Abel and Yin had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Van Abel and Yin contributed equally to this work.
Concept and design: Sauer, Glasgow, Habermann, Moore, Van Abel, Yin.
Acquisition, analysis, or interpretation of data: Sauer, Daher, Lohse, Glasgow, Habermann, Douse, Ighodaro, Van Abel, Yin.
Drafting of the manuscript: Sauer, Daher, Glasgow, Ighodaro, Van Abel, Yin.
Critical revision of the manuscript for important intellectual content: Sauer, Lohse, Glasgow, Habermann, Douse, Moore, Ighodaro, Van Abel, Yin.
Statistical analysis: Sauer, Lohse, Glasgow.
Administrative, technical, or material support: Ighodaro.
Supervision: Habermann, Moore, Van Abel, Yin.
Conflict of Interest Disclosures: None reported.
Additional Contributions: We thank Larry J. Prokop, MLS, of the Mayo Clinic Libraries for his substantial contribution to our systematic review process. No compensation was provided for his contributions.
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