Trends in FDA cancer registration trial design over time, 1969-2020.
Warner J, Sethi T, Rivera D, Venepalli N, Osterman T, Khaki A, Rubinstein S. Trends in FDA cancer registration trial design over time, 1969-2020. Journal Of Clinical Oncology 2020, 38: 2060-2060. DOI: 10.1200/jco.2020.38.15_suppl.2060.Peer-Reviewed Original ResearchTrial designFDA approvalImmunotherapy trialsRegistration trialsCommon trial designOverall survival endpointOncology drug approvalsClass switchFDA package insertsCancer drug indicationsStudy drugCytotoxic therapyControl armTherapeutic approachesPackage insertsRCTsRCT designIndication approvalsOncology drugsLog-linear regressionSurvival endpointsTherapyTrialsDrug approvalNew drugs