Background
To develop effective novel treatment strategies for Cholangiocarcinoma that cater to patients from diverse backgrounds, all racial groups must have equal opportunities to participate in clinical trials.
Methods
Using ClinicalTrials.gov, a web-based resource that registers all studies meeting the definition of a clinical trial according to the International Committee on Medical Journal Editors, we identified all phase 1 to phase 4 cholangiocarcinoma clinical trials registered from 2009 to 2022. We manually abstracted data on the racial distribution of enrolled participants, sex distribution, trial phase, location, and year of trial reporting. We calculated observed ratios of racial participation and compared them with the prevalence of Cholangiocarcinoma from the National Cancer Database to define the enrollment factor. We then conducted subgroup racial distribution based on the trial phase and location. We further evaluated trends in racial disparity within clinical trial enrollment over the years.
Results
We identified 57 clinical trials related to Cholangiocarcinoma between 2009 and 2022, of which 91.2% were done in Europe or the United States. Most of these were phase 2 clinical trials (59.6%). The racial distribution of enrolled participants was publicly available in 33 (63.4%) clinical trials. The race distribution of enrolled subjects was reported in 50% of Phase 1, 66.7% in Phase 3, 70.9% in Phase 2and 100% in Phase 4. The race distribution among 1946 study participants in 52 clinical trials was: 76% Whites (1479), 7.1% Blacks (138), 8.9% Asians (174), 3.8% other races (74), and 4.1% (81) subjects with unreported race. The same race distribution trend was observed across all subgroups of clinical trials based on phase. The enrolment factor for blacks was 0.87, 1.48 for Asians and 0.97 for Whites (Table 1). From 2009 to 2022, yearly trends for the absolute number of clinical trial enrollees showed a decrease in the distribution of blacks from 16% to 5.4 %, whereas an increase in Asian enrollment went from 4% to 23%. Strategies to implement equitable representation in clinical trials in Cholangiocarcinoma are needed.
