Racial and ethnic disparities in multinational phase III clinical trials in liver and biliary tract cancer.

Abstract

497 Background: Racial and ethnic diversity ensures validity of clinical research and opens novel oncologic treatments to all population groups. Hispanics and non-Hispanic Blacks (NHB) are the largest racial/ethnic groups in the United States after non-Hispanic Whites (NHW). Hispanics accounted for 19%, while NHB accounted for 14% of the population in 2021. From 2012 to 2019 the proportion of hepatocellular carcinomas (HCC) and biliary tract cancers (BTC) occurring in Hispanics was 23.2% and 22.6% respectively; the proportion of HCC and BTC occurring in NHB was 11.1% and 8.3% respectively. We examined the participation of NHB and Hispanics in multinational phase III clinical trials of HCC and BTC in the last ten years. A participant to population ratio (PPR) of 0.8-1.2 reflects adequate ethnic/racial representation; a lower PPR indicates underrepresentation. Methods: A database search was performed in PubMed, Embase and Web of Science: Core Collection (Cl for multinational phase III clinical trials of HCC or BTC, studying first and second line treatments published from August 2012 to August 2022.Trials meeting these criteria were identified and the percentage of NHB and Hispanics included was calculated and compared to the proportion of NHB and Hispanics affected by HCC and BTC as per the National Cancer Institute Surveillance, Epidemiology, and End Results Program. Results: Eighteen multinational phase III clinical trials studying first- and second-line treatments for HCC and BTC were identified. The trials enrolled a total of 12464 patients; 27% (n=5 trials) did not report racial/ethnic characteristics. Of the 9991 patients included in trials for which race/ ethnicity was provided, 11 (0.08%) were Hispanics and 88 (0.7%) were NHB. The participant to population ratio (PPR) in Hispanics for HCC was 0.003 and 0 for BTC, meanwhile the PPR in NHB was 0.6 for HCC and 0 for BTC. Conclusions: NHB and Hispanics are underrepresented in HCC and BTC in multinational phase III trials relative to the U.S population. Most patients included in trials were Asian, consistent with the global incidence of HCC. It may be important for phase III clinical trials seeking FDA approval to require mandatory racial/ethnic diversity that is reflective of the US population.