Ethnic disparities in clinical trials for FDA-approved drugs in prostate cancer: A post–COVID-19 era analysis (2020-2024).

25 Background: It is known that ethnic and racial inequality in participation in oncology clinical trial is a contemporary problem. Efforts have been made by NCI and FDA to address cancer disparities as per new policies placed in 2017. Despite these efforts, there are still disparities in cancer treatment and clinical trial participation. There is paucity of data in participation of minorities in the post COVID-19 era of the FDA approved agents in Prostate Cancer. Methods: From 2020-2024, a total of 4,744 patients participated in the seven clinical trials (MAGNITUDE, TALAPRO-2, VISION, PROPEL, ARASENS, HERO, PROfound and TRITON3) that led to FDA approval of new agents or indications to treat patients with prostate cancer. All clinical trials were industry-sponsored. We assessed and tabulated the reporting of racial demographics within these trials employing chi-square statistics and machine learning algorithms to compare participation rates among White, Black, Asian and Hispanic patients against SEER data on prostate cancer incidence. Results: Among the eight trials, five (ARASENS, MAGNITUDE, PROPEL, TALAPRO, TRITON-3) reported racial data in White, Asian and Black participants, but only one reported data on Hispanics (MAGNITUDE). Our analysis revealed that in the five trials providing racial data, 68% were White indicating statistically significant overrepresentation (p<0.001), Black participation was only 3% signifying statistically significant underrepresentation with (p<0.0001). In the only trial with data in Hispanics, there was a 12.1% participation of Hispanics with no significant disparity observed (p=1). Conclusions: Lack of representation of minorities persist in post COVID area FDA approved drugs clinical trials in prostate cancer. Lack of a more comprehensive data in race have also been seen in recent trials. Further implementation of policies for better data capture and standardization in the nomenclature of ethnicity should be pursued. Additionally, in international collaboration trials, a separate data on US participants utilizing NCI SEER data ethnicity nomenclature should be considered.