2025
Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time.
Miller J, Pelletiers W, Gross C, Mello M, Ramachandran R, Schwartz J, Suttiratana S, Varma T, Ross J. Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time. JCO Oncology Practice 2025, op2400563. PMID: 40493876, DOI: 10.1200/op-24-00563.Peer-Reviewed Original ResearchFood and Drug AdministrationOncology therapeuticsLatino patientsBlack patientsTherapeutic approvalsOlder adultsRetrospective cross-sectional studyUS Food and Drug AdministrationTrial characteristicsMinoritized patientsUS patient populationSpot trialsPivotal trialsPatient demographicsPatient populationRepresentative patientsTrial enrollmentUS Census dataDrug AdministrationPatientsStudy of trialsTrialsOncologyWomenClinical trial diversity
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
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