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
2024
The Promise and Perils of Diversity Action Plans for Clinical Trials
Varma T, Bierer B, Hantel A. The Promise and Perils of Diversity Action Plans for Clinical Trials. JAMA 2024, 332: 1787-1788. PMID: 39302826, PMCID: PMC11938119, DOI: 10.1001/jama.2024.18225.Peer-Reviewed Original Research
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
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