Assessing Population Diversity in Phase <scp>III</scp> Trials of Cancer Drugs Supporting <scp>FDA</scp> Approval in Solid Tumors

Our study aimed to assess inequities in the clinical trial participation for selected patient groups. We searched Food and Drug Administration (FDA) database extracted phase-III data from MEDLINE each approved drug by FDA between January 1, 2006, June 30, 2020. analyzed inclusion/exclusion criteria, according gender, ethnic group, performance score, positivity of HBV HCV, HIV, having comorbidities brain metastasis. compared findings with that general population retrieving Surveillance, Epidemiology End Results (SEER) database. identified 142 phase III pivotal oncology trials enrolled 105 397 patients. The proportion female patients was lower than their relative prevalence SEER region (36% vs 49.6%, P < .001). rates black included were (2.1% 9.8%, 1.3% 0.8% had HCV infections, respectively. patients' numbers organ dysfunction not established due insufficient trials. 1.6% all controlled Black patients, women metastasis or underrepresented. underscores importance expanding criteria be more representative seen practice.