2023
Data transparency and demographic representation in approval packages of FDA-approved oncology drugs from 2012-2021.
Liu J, Jayaram G, Varma T, Sammut S, Guerra C, Miller J. Data transparency and demographic representation in approval packages of FDA-approved oncology drugs from 2012-2021. Journal Of Clinical Oncology 2023, 41: 1594-1594. DOI: 10.1200/jco.2023.41.16_suppl.1594.Peer-Reviewed Original ResearchPivotal trialsDrug approval packagesClinical trialsApproval packagesNovel cancer therapeuticsDemographic dataCancer therapeuticsUS cancer populationUS Cancer StatisticsCross-sectional studyOncology clinical trialsPercentage of participantsClinical trial infrastructurePercentage of trialsCancer populationProportion of trialsCancer statisticsDrug AdministrationOncology drugsTrial infrastructureCancer typesData reportingU.S. FoodOlder adultsTrials
2021
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatients