2024
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpoint
2021
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
Egilman AC, Kapczynski A, McCarthy ME, Luxkaranayagam AT, Morten CJ, Herder M, Wallach JD, Ross JS. Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration. The Journal Of Law, Medicine & Ethics 2021, 49: 456-485. PMID: 34665102, DOI: 10.1017/jme.2021.67.Peer-Reviewed Original ResearchOptimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada
Egilman AC, Ross JS, Herder M. Optimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada. Canadian Medical Association Journal 2021, 193: e1616-1618. PMID: 34663613, PMCID: PMC8547254, DOI: 10.1503/cmaj.210877-f.Commentaries, Editorials and LettersOptimizing the data available via Health Canada’s clinical information portal
Egilman AC, Ross JS, Herder M. Optimizing the data available via Health Canada’s clinical information portal. Canadian Medical Association Journal 2021, 193: e1305-e1306. PMID: 34426449, PMCID: PMC8412426, DOI: 10.1503/cmaj.210877.Commentaries, Editorials and Letters
2020
Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction
Jackevicius CA, Krumholz HM, Ross JS, Koh M, Chong A, Austin PC, Stukel TA, Azizi P, Ko DT. Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction. Canadian Journal Of Cardiology 2020, 36: 1633-1640. PMID: 32416066, DOI: 10.1016/j.cjca.2020.01.024.Peer-Reviewed Original ResearchConceptsPrior myocardial infarctionMyocardial infarctionStable patientsPopulation-based observational studyAngina 1 yearDeath/hospitalizationHistory of revascularisationBeta-blocker useMajor cardiovascular eventsHospital discharge diagnosisUse of BBsIndividual end pointsContemporary clinical trialsYears of ageCardiovascular eventsIndex dateCohort studyComposite outcomeBB useHeart failureMedian agePrimary outcomeClinical outcomesAtrial fibrillationDischarge diagnosis
2019
Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies
Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. Journal Of General Internal Medicine 2019, 34: 2319-2321. PMID: 31313117, PMCID: PMC6848610, DOI: 10.1007/s11606-019-05149-6.Peer-Reviewed Original Research
2017
Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open 2017, 7: e014582. PMID: 28179418, PMCID: PMC5306516, DOI: 10.1136/bmjopen-2016-014582.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyCohort studyClinical impactRare diseaseHealth CanadaNew therapeuticsLikely clinical impactPotential clinical impactUS patientsAvailable therapiesNovel mechanismDrug AdministrationMedicines AgencyNovel therapeuticsUS approvalNew drugsDrugsFDA submissionsReview outcomesTherapeuticsSafety concernsDiseaseFDAMechanistic noveltyAffected population
2014
Impact of Drug Policy on Regional Trends in Ezetimibe Use
Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of Drug Policy on Regional Trends in Ezetimibe Use. Circulation Cardiovascular Quality And Outcomes 2014, 7: 589-596. PMID: 24895451, PMCID: PMC4222175, DOI: 10.1161/circoutcomes.114.001023.Peer-Reviewed Original ResearchImpact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada
Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada. American Heart Journal 2014, 167: 683-689. PMID: 24766978, PMCID: PMC4215424, DOI: 10.1016/j.ahj.2014.01.014.Peer-Reviewed Original ResearchConceptsUse of ezetimibeENHANCE trialEzetimibe useProgression of atherosclerosisMain outcome measuresAtherosclerosis regression trialsMonthly numberOutcome measuresRegression trialsEzetimibeIMS HealthCommon evidence baseEvidence baseTrialsUnited StatesUtilization patternsFurther investigationDifferent utilization patternsPopulationDifferent patternsUse trendsAtherosclerosisSimvastatinProgression
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority
2011
Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study
Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. The BMJ 2011, 343: d5621. PMID: 21990257, PMCID: PMC3191201, DOI: 10.1136/bmj.d5621.Peer-Reviewed Original ResearchUse 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
2009
Health Care Choices and Decisions in the United States and Canada
Ross JS, Detsky AS. Health Care Choices and Decisions in the United States and Canada. JAMA 2009, 302: 1803-1804. PMID: 19861673, PMCID: PMC2835156, DOI: 10.1001/jama.2009.1566.Commentaries, Editorials and Letters
2008
Comparison of the US and Canadian Health Care Systems: A Tale of 2 Mount Sinai’s
Ross JS, Detsky AS. Comparison of the US and Canadian Health Care Systems: A Tale of 2 Mount Sinai’s. JAMA 2008, 300: 1934-1936. PMID: 18940983, DOI: 10.1001/jama.300.16.1934.Commentaries, Editorials and LettersUse of Ezetimibe in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Krumholz HM. Use of Ezetimibe in the United States and Canada. New England Journal Of Medicine 2008, 358: 1819-1828. PMID: 18375999, DOI: 10.1056/nejmsa0801461.Peer-Reviewed Original ResearchConceptsLipid-lowering agentsLow-density lipoprotein cholesterolLipid-lowering guidelinesRatio of prescriptionsUse of ezetimibeTreatment of hyperlipidemiaStatin useCohort studyLipoprotein cholesterolSecondary preventionStatin prescriptionClinical outcomesPrescribing practicesEzetimibeIMS HealthUnited StatesPrescriptionMonthly numberFirst optionDistinct patterns