Population diversity in phase III trials of cancer drugs supporting FDA approval in solid tumors

Pivotal studies supporting FDA approval of cancer drugs for solid tumors may have stringent inclusion or exclusion criteria. Analysis of 142 phase III studies (105,397 patients) of drugs approved between January 1^st, 2006, and June 30^th, 2020 found that the proportion of female patients in trials was lower than their relative prevalence in the general population from the SEER database (36% versus 49,6%; p<0.001). Also black patients (2.1% versus 9.8%; p<0.001), patients with HBV and HCV infections and patients with brain metastases were underrepresented in the studies.