2023
Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study
Varma T, Mello M, Ross J, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023, 2: e000395. PMID: 36936269, PMCID: PMC9951369, DOI: 10.1136/bmjmed-2022-000395.Peer-Reviewed Original ResearchRetrospective cross-sectional studyCross-sectional studyPivotal trialsOlder adultsSectional studyNovel oncology therapeuticsUS cancer populationUS Cancer StatisticsUS patient populationAmerican Cancer SocietyPatient populationCancer populationOncology therapeuticsCancer SocietyCancer statisticsNovel cancer therapeuticsOncology trialsBaseline scoresPatientsUS FoodDrug AdministrationTrial dataStudy participantsTrialsEthics Committee
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