2024
Evaluation of the study of control arms in randomized clinical trials of cancer.
Jain S, Zauderer M, Sethi T, Schoen M, Rubinstein S, Nguyen R, Nagpal S, Mohan S, Madireddy S, Lythgoe M, Liang W, Kulkarni A, Kothari S, Hilal T, Hadfield M, Goyal G, Ganta T, Dholaria B, Brown A, Warner J. Evaluation of the study of control arms in randomized clinical trials of cancer. Journal Of Clinical Oncology 2024, 42: 11023-11023. DOI: 10.1200/jco.2024.42.16_suppl.11023.Peer-Reviewed Original ResearchRandomized clinical trialsSystemic anti-cancer therapyCancer randomized clinical trialsControl armSuccess rateClinical trials of cancerFisher's exact testAnti-cancer therapyTrial success ratesStudy publication yearExact testPatient convenienceRegimensClinical trialsHighest success rateExperimental armCancer typesCancerContext of treatmentPublication yearTrialsDoseNon-cancerEfficacyDyads
2020
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