United States-Based Colorectal Cancer Surgical Trials Lack Representation and Adequate Reporting of Racially and Ethnically Diverse Participants: Systematic Review and Regression Analysis.

BACKGROUND:Despite the established National Institute of Health Revitalization Act, which aims to include ethnic and racial minority representation in surgical trials, racial and ethnic enrollment disparities persist.OBJECTIVE:To assess the proportion of patients from minority races and ethnicities that are included in colorectal cancer surgical trials and reporting characteristics.DATA SOURCES:Search was performed using MEDLINE (Ovid), Embase, Web of Science, and Cochrane Central.STUDY SELECTION:Inclusion criteria included 1) trials performed in the United States between January 1, 2000, and May 30, 2022; 2) patients with colorectal cancer diagnosis; and 3) surgical intervention, technique, or postoperative outcome. Trials evaluating chemotherapy, radiotherapy, or other nonsurgical interventions were excluded.INTERVENTIONS:Pooled proportion and regression analysis was performed to identify the proportion of patients by race and ethnicity included in surgical trials and the association of year of publication and funding source.MAIN OUTCOME MEASURES:Proportion of trials reporting race and ethnicity and proportion of participants by race and ethnicity included in surgical trials.RESULTS:We screened 10,673 unique publications, of which 80 were examined in full text. Fifteen studies met our inclusion criteria. Ten (66.7%) trials did not report race, 3 reported races as a proportion of White participants only, and 3 reported 3 or more races. There was no description of ethnicity in 11 (73.3%) trials, with 2 describing "non-Caucasian" as ethnicity and 2 describing only Hispanic ethnicity. Pooled proportion of White participants was 81.3%, of Black participants was 6.2%, of Asian participants was 3.6%, and of Hispanic participants was 3.5%.LIMITATIONS:A small number of studies was identified that reported racial or ethnic characteristics of their participants.CONCLUSIONS:Both race and ethnicity are severely underreported in colorectal cancer surgical trials. To improve outcomes and ensure the inclusion of vulnerable populations in innovative technologies and novel treatments, reporting must be closely monitored.