Geographic and racial disparities in bi-specific antibodies trials access for diffuse large B-cell lymphoma.

Abstract

1525 Background: The trials of bispecific antibodies to treat diffuse large B-cell lymphoma (DLBCL) have increased exponentially. However, there is a geographic limitation to offering these trials and universal access appears to be limited. Here, we investigate the geographical and racial disparities in accessing bispecific antibodies trials for DLBCL. Methods: We searched ClinicalTrials.gov using the terms for DLBCL and bispecific antibodies. A total of 13 out of 51 clinical trials with one or more open sites in the United States (US) were included in this systematic review. 2020 US Census Bureau data was used to obtain data on race and ethnicity. Analysis for this study was performed using SPSS version 26. Results: The majority of the included trials were Phase I (62%) followed by Phase II (23%), and Phase I/II (15%). A total of 885 participants were either enrolled or expected to enroll in these clinical trials. Nine (69%) clinical trials were only open in the US while 4 (31%) clinical trials were open in the US and other countries. The majority of the trials were funded by the pharmaceutical industry 62%. There were 50 unique study sites distributed over 24 states with a 2.4 (1-10) mean number of trials per state and 9.9 (1-39) mean number of sites per trial. Study sites were distributed in 24 different states. Midwestern states had the highest number of trials 28%, followed by Southern 26%, Northeastern 24%, and Western 22%. The highest number of study locations (10) and the highest number of open studies (10) were in California. Twenty-seven states had no open bispecific antibodies trials including three in the Northeast (Maine, Rhode Island, and Vermont), five in the Midwest (Illinois, Indiana, Nebraska, North and South Dakota), eight in the South (Delaware, Virginia, District of Columbia, West Virginia, Mississippi, Arkansas, Louisiana, and Oklahoma), and eleven in the West (Arizona, Colorado, Idaho, New Mexico, Montana, Nevada, Wyoming, Alaska, Hawaii, Oregon, and Washington). Using US Census Bureau data, only 20% of African Americans (AA) (8 349 699 of 41 104 200) lived in a county with a bispecific antibodies trial. There were only five states (21%) with 50% or more of the AA population living in a county with an open bispecific antibodies trial and seven states (29%) with 30-49.9% of their AA county residents. Five states (21%) had less than 10% of the AA population living in a county with an open bispecific antibodies trial. Nine (90%) out of ten states with the highest proportion of AA residents (18.6%-41.4%) have no (five states) or only one clinical trial site (four states). Conclusions: There is significant geographic and racial disparity in accessing bispecific antibodies trials for DLBCL. Strategies should be framed to address the causes of the observed disparities and to improve access to these trials.