2024
Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022
Swanson M, Uyeki C, Yoder S, Dhruva S, Miller J, Ross J. Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014–2022. Medical Devices Evidence And Research 2024, 17: 165-172. PMID: 38707869, PMCID: PMC11067925, DOI: 10.2147/mder.s457152.Peer-Reviewed Original ResearchFood and Drug AdministrationHigh-risk cardiovascular devicesSubgroup analysisPremarketing studiesUS Food and Drug AdministrationResults of subgroup analysisParticipation of older adultsStudy participantsClinical trialsSocioeconomic positionTrial populationDrug AdministrationStudy populationConduction of subgroup analysisDemographic dataOlder adultsReporting of demographicsSubgroupsPatients' socioeconomic position.PatientsTrials
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
2018
Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population. BMJ Open 2018, 8: e021685. PMID: 30037874, PMCID: PMC6059296, DOI: 10.1136/bmjopen-2018-021685.Peer-Reviewed Original ResearchConceptsSystolic Blood Pressure Intervention TrialFramingham risk scoreCardiovascular riskRisk scoreStudy populationStudy participantsNon-diabetic adultsTotal study populationHigh-risk populationClinical trial dataClinical trial sitesTrial populationIntervention trialsRisk populationsNew England JournalIndependent investigatorsTrial dataSecondary analysisSPRINT trialSPRINT dataTrialsRiskScoresParticipantsPopulation