2025
The impact of food and drug administration-based eligibility criteria on demographic representation in current phase III clinical trials for newly diagnosed breast cancer.
Varma T, Merz L, Wang Y, Cronin A, Freedman R, Abel G, Hantel A. The impact of food and drug administration-based eligibility criteria on demographic representation in current phase III clinical trials for newly diagnosed breast cancer. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.e23021.Peer-Reviewed Original ResearchFood and Drug Administration criteriaFood and Drug AdministrationFood and Drug Administration guidanceEligibility criteriaNH WhitesNH BlackClinical trialsSafety dataNewly diagnosed breast cancerPhase III clinical trialsMedian differencePhase III trialsUS Food and Drug AdministrationCurative-intent therapyProportion of patientsIII clinical trialsNon-Hispanic (NH)Electronic health record databaseRestrictive eligibility criteriaIII trialsCreatinine clearancePrimary endpointMedian ageSecondary endpointsInvestigational agents
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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