Racial demographic reporting in clinical trials supporting NCCN gastric cancer guidelines.

Abstract

823 Background: Gastric cancer exhibits significant global and racial disparities in incidence and mortality, with higher rates observed in Asian, Hispanic, and Black populations compared to non-Hispanic Whites. The NCCN guidelines are critical for standardizing care, yet the racial and ethnic composition of the trials that inform these guidelines is not well described. Methods: We reviewed 412 references from the NCCN Gastric Cancer Guidelines (Version 2.2025), resulting in 95 eligible clinical trials. We evaluated each study for the reporting of race, geographic location, and publication year. We performed descriptive analyses and used Fisher's exact test to evaluate trends in reporting over time and across U.S.-based vs. international studies. Results: Of 95 eligible trials, only 27 (28.4%) reported racial data. The reporting frequency increased significantly over time, from 0% in 2005–2009 to 48.1% in 2020–2025 (p = 0.001). U.S.-based studies reported race more frequently (14/34, 41.2%) than international studies (13/61, 21.3%). Among reporting trials, the participant population was predominantly White (55.2%) and Asian (32.7%), with stark underrepresentation of Black (1.2%), Hispanic (0.8%), American Indian/Alaska Native (0.5%), and Native Hawaiian/Pacific Islander (0.1%) patients. Conclusions: The evidence base for NCCN Gastric Cancer guidelines suffers from a profound lack of racial diversity. This stems from a reliance on international trials often conducted in more racially homogeneous populations. While high Asian enrollment reflects the disease's global epidemiology, the resulting data lacks generalizability for diverse nations like the U.S., creating a risk of perpetuating care disparities. Our findings issue a critical call for mandated, standardized racial and ethnic reporting in all trials to ensure guidelines are equitable and effective for all patients. Racial and ethnic composition in gastric cancer clinical trials over time. Time Block White (%) Black (%) Asian (%) Hispanic (%) AI/AN (%) NH/PI (%) More than one race (%) 2000–2004 68.3% 16.8% 4.0% 10.9% 0.0% 0.0% 0.0% 2005–2009 - - - - - - - 2010–2014 44.4% 1.8% 40.4% 0.0% 0.0% 0.0% 0.0% 2015–2019 75.4% 0.3% 19.7% 0.0% 0.0% 0.0% 2.4% 2020–2025 52.1% 0.8% 35.2% 0.9% 0.8% 0.2% 1.0% Total 55.2% 1.2% 32.7% 0.8% 0.5% 0.1% 1.1% The 1980-1999 period (n=3 trials) and 2005–2009 period (n=17 trials) are excluded from the table as no trials reported racial data. AI/AN = American Indian/Alaska Native; NH/PI = Native Hawaiian/Pacific Islander. Percentages are calculated from the total number of participants in trials that reported race within each time block. Totals may not sum to 100% due to rounding.