2024
Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapy
2023
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original Research
2022
Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance
Xiao R, Ross JS, Gross CP, Dusetzina SB, McWilliams JM, Sethi RKV, Rathi VK. Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. JAMA Internal Medicine 2022, 182: 603-611. PMID: 35435948, PMCID: PMC9016607, DOI: 10.1001/jamainternmed.2022.1022.Peer-Reviewed Original ResearchConceptsCancer CenterCancer therapyCross-sectional studyHospital acquisition costNational Cancer InstituteCross-sectional analysisPrimary outcomeSecondary outcomesPrivate health insuranceMAIN OUTCOMEClinical careCancer InstituteMedicare Part B spendingTherapyAcquisition costsPart B spendingHospitalCancer treatmentHealth insuranceFinancial burdenB spendingPatientsSame centerOutcomesPayersMedicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure
Faridi K, Dayoub E, Ross J, Dhruva S, Ahmad T, Desai N. Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure. Journal Of The American College Of Cardiology 2022, 79: 2516-2525. PMID: 35738713, DOI: 10.1016/j.jacc.2022.04.031.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsAngiotensin receptor neprilysin inhibitorQuadruple therapyOOP costsMedicare coveragePocket costsAngiotensin-converting enzyme inhibitorPrior authorizationAngiotensin receptor blockersQuadruple drug therapyCotransporter 2 inhibitorsMineralocorticoid receptor antagonistsReduced ejection fractionDrug plansReceptor blockersEjection fractionHeart failureDrug therapyReceptor antagonistPrescription drug plansMedicare patientsEnzyme inhibitorsTherapyRegimensMedication prices
2020
Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals
Solotke MT, Liu P, Dhruva SS, Gulanski B, Shah ND, Ross JS. Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals. LGBT Health 2020, 7: 137-145. PMID: 32267818, DOI: 10.1089/lgbt.2019.0306.Peer-Reviewed Original Research
2014
Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis
Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis. JAMA Internal Medicine 2014, 174: 1176-1182. PMID: 24796406, PMCID: PMC4124903, DOI: 10.1001/jamainternmed.2014.1371.Peer-Reviewed Original ResearchConceptsACCORD lipid trialACCORD-LipidFibrate useTrial interpretationImproved cardiovascular outcomesCross-sectional studyCross-sectional analysisStatin therapyCardiovascular outcomesCardiovascular riskDiabetes (ACCORD) trialDiabetes mellitusConflicts of interestTrialsPatientsFenofibrateAuthor conflictsLipid componentsMellitusTherapyPhysiciansMonths
2013
When Choosing Statin Therapy: The Case for Generics
Green JB, Ross JS, Jackevicius CA, Shah ND, Krumholz HM. When Choosing Statin Therapy: The Case for Generics. JAMA Internal Medicine 2013, 173: 229-232. PMID: 23303273, DOI: 10.1001/jamainternmed.2013.1529.Commentaries, Editorials and Letters
2011
Use of Fibrates in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of Fibrates in the United States and Canada. JAMA 2011, 305: 1217-1224. PMID: 21427374, PMCID: PMC3332101, DOI: 10.1001/jama.2011.353.Peer-Reviewed Original ResearchMeSH KeywordsCanadaCardiovascular DiseasesCohort StudiesCosts and Cost AnalysisDiabetes Mellitus, Type 2Drug CostsDrugs, GenericFenofibrateFibric AcidsHealth ExpendituresHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsMedical AuditPractice Patterns, Physicians'PrescriptionsUnited StatesConceptsUse of fibratesRole of fibratesObservational cohort studyIMS Health dataFenofibrate useCardiovascular riskCohort studyDiabetes (ACCORD) trialClinical benefitFibratesMonthsPrescriptionUnited StatesPatientsNegative resultsFenofibrateHealth dataCurrent useGeneric formulationPopulationStatinsTherapyTrials