Diversity and representation in head and neck cancer trials following the 2010 Affordable Care Act.

e13827 Background: Racial and ethnic disparities across cancer subtypes are well documented. Clinical trials aim to raise the standard of care and push medicine forward, but often underrepresent minority groups and underreport patient demographics, limiting their applicability to the diverse real-world population. By expanding health insurance for low-income individuals, the 2010 Affordable Care Act (ACA) aimed to improve minority healthcare (HC) access. General HC utilization trends following its implementation have been explored, but head and neck cancer (HNC) specific impacts remain understudied. Here, we analyzed racial and ethnic trends in HNC presentation and representation in HNC trials pre- and post-ACA. Methods: A database of all industry, NIH, and United States government agency-funded HNC clinical trials reported on ClinicalTrials.gov was created. Racial and ethnic representation on published trials were stratified by start date permissive of the four-year lag from legislation to implementation: 78 trials begun through 2014 were considered pre-ACA, while 33 trials begun 2015 onwards were considered post-ACA. In total, 18033 patients across 111 trials from 2000 to 2020 were analyzed. Clinical trial subgroup enrollment rates were evaluated alongside US HNC incidence demographics obtained from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) registry. Results: Differences in HNC incidence rates were evident pre- and post-ACA. Most notably, the SEER incidence of HNC in Black or African American (B/AA) individuals decreased by ~15% after the ACA (9.2% pre-ACA; 7.8% post-ACA) and increased by ~20% among Asians/Pacific Islanders (AAPI) and Hispanics/Latinos (HL). B/AA enrollment in HNC research trials worsened pre- to post-ACA (OR: pre-ACA 0.68, p = 0.001; post-ACA 0.42, p = < 0.001). Females and HL patients were underrepresented, but there were incremental improvements post-ACA (Female OR: pre-ACA 0.62, p = < 0.001; post-ACA 0.68, p = < 0.001 | HL OR: pre-ACA 0.56, p = < 0.001; post-ACA 0.73, p = 0.026). Although not statistically significant, overrepresentation of American Indian and Alaskan Natives, Whites, and males improved post-ACA, but worsened within AAPI patients. Conclusions: Although intended to improve healthcare access for minorities, there was a 15% decrease in HNC incidence captured by SEER among B/AA patients after the ACA, suggesting it fell short of achieving its goals. Enrollment of females and HL patients on HNC clinical trials improved slightly post-ACA, but they remained underrepresented. Representation of B/AA patients on HNC clinical trials significantly worsened after the ACA. HNC trials are not representative of the diversity of the HNC patient population, a trend which did not improve with implementation of the ACA. These data may help inform future legislative goals and directives to improve diversity on clinical trials.