Racial disparities in the intervention trials in colon cancer.

person Abhinav Vyas North Alabama Medical Center, Florence, AL info_outline Abhinav Vyas, Dania Kaur, Saloni Savani, Moazzam Shahzad, Rohit Singh, Udit Yadav, Muhammad Umair Mushtaq, Akshee Batra

Authors person Abhinav Vyas North Alabama Medical Center, Florence, AL info_outline Abhinav Vyas, Dania Kaur, Saloni Savani, Moazzam Shahzad, Rohit Singh, Udit Yadav, Muhammad Umair Mushtaq, Akshee Batra Organizations North Alabama Medical Center, Florence, AL, Department of Internal Medicine, Willis-Knighton Health System, Shreveport, LA, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL, University of Vermont Medical Center, Burlington, VT, Mayo Clinic Rochester, Rochester, MN, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS, University of Vermont, Burlington, VT Abstract Disclosures Research Funding No funding sources reported Background: Colorectal cancer (CRC) is the third-leading cancer worldwide and racial minorities bear a disproportionate burden of this disease. Methods: We searched the clinicaltrials.gov database for all the completed clinical trials conducted on adult patients until 2023 in the United States. In intervention trials, we manually abstracted data on the racial distribution of enrollees, phases, tumor histology, intervention type, and year of completion. We divided interventions into chemotherapy, radiotherapy, surgery, immunotherapy, behavioral, diagnostic tests, and others. To quantify the racial disparity, we calculated the enrolment ratio (ER) as the observed ratios of racial participation in the study compared to the prevalence in colorectal cancer per the 2009-2019 Surveillance, Epidemiology and End Results (SEER) database. We also conducted subgroup racial enrollment based on clinical trial and type of intervention. Results: We identified 394 studies, of which 252 studies (64%) had racial distribution published, including 138814 participants. Most studies were phase 2 trials (168), followed by phase 1/2 trials (49) and phase 3 studies (43). The racial breakdown included 88677 White participants (63.9%), 23230 were African Americans (16.7%), 9963 were Asians (7.1%), 4398 were of other races (3.2%), and 12546 were of unknown race (9.0%). The frequency of including racial data was 100% in Phase 1 studies, 56.5% in Phase 2, 58.1% in Phase 3, and only 16% in Phase 4. A total of 185 were immunotherapy trials, out of which 63 studied chemotherapies, radiotherapy and/ or surgery along with immunotherapy. Racial enrolment data was reported in 68.6 %, 58% and 59.3% in immunotherapy, chemotherapy, and radiotherapy interventions respectively. The ERs of whites, blacks, and Asians were 0.8, 1.3, and 0.9, respectively (Table). However, ER in subgroups with specific interventions, such as chemotherapy, immunotherapy, and radiotherapy, were 0.5, 0.4, and 0.6, respectively. Conclusions: African Americans are underrepresented in CRC intervention trials. Equal access and tailored strategies for cultural and linguistic differences are needed for fair participation. Racial distribution in colorectal cancer trials. White Black Asian Proportion of trial enrolment (%) 63.9 16.7 7.1 Enrolment Ratio Total 0.8 1.3 0.9 Immunotherapy 1 0.4 1.3 Chemotherapy 1 0.5 1 Radiotherapy 1 0.6 0.4