Examining disparities in cancer pain-specific clinical trials.

Abstract

e18513 Background: Clinical trials overall have been found to lack proportional representation of minority patient populations. This limits their generalizability as well as progress towards equitable care. This work examines the racial representation of cancer pain related clinical trials in the United States. Methods: All trials with posted results that had started between 1999 to 2019 on ClinicalTrials.gov were examined, excluding trials that included sites that were not within the United States and trials without demographic results posted on ClinicalTrials.gov. We calculated enrollment fractions (EFs) for each group as defined by the Surveillance, Epidemiology, and End Results (SEER) database cancer prevalence by race. Results: As of February 10, 2022 there were 340 trials on ClinicalTrials.gov which were categorized as “Cancer Pain” related. 84 of these studies had posted results. An additional 19 were excluded due to having non-US sites and 31 were excluded due to absence of demographic data, leaving at total of 34 studies for this evaluation (n = 2,767 patients). Examination of clinical trial enrollment was separated by decade (1999-2009 and 2010-2019), utilizing available SEER cancer prevalence by race data for 2009 (as a comparator for 1999-2009) and most recent available 2018 data (as a comparator for 2010-2019). Total enrolled patients in cancer-specific trials between 1999-2009 was 817; 85.1% white, 7.6% black/African American, 1.8% Asian/Pacific Islander. When compared to the SEER 2009 prevalence for all cancer, the EF was 97.5%, 91.6%, and 83% for white, black and Asian groups respectively. Between 2010-2019 there were 1950 enrolled patients, 85.6% white, 9.9% black/African American, 2.1% Asian/Pacific Islander. When compared to the SEER 2018 prevalence for all cancer, the EF was 101.2%, 102.1%, and 61.8% for white, black and Asian groups respectively. Conclusions: In the examination of racial representation within cancer pain-specific trials relative to all cancer prevalence between 1999-2009 and 2010-2019, there appears to be a slight increase in relative representation of white participants (+3.7%), and an even greater increase in representation of black/African American participants (+10.5%). Asian/Pacific Islanders had a notable drop in relative representation (-21.2%). This data is suggestive that minority representation in cancer-pain specific trials has become more representative with regards to black/African Americans. However, there is a large relative decrease in Asian/Pacific Islander representation in cancer pain-specific trials. Given the importance of cancer pain management, it is vital that we move toward equitable accrual to these clinical trials such that they that accurately reflect racial groups in the United States population.