2021
Uptake of evidence by physicians: De-adoption of erythropoiesis-stimulating agents after the TREAT trial
Vu K, Zhou J, Everhart A, Desai N, Herrin J, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Uptake of evidence by physicians: De-adoption of erythropoiesis-stimulating agents after the TREAT trial. BMC Nephrology 2021, 22: 284. PMID: 34419007, PMCID: PMC8379779, DOI: 10.1186/s12882-021-02491-y.Peer-Reviewed Original ResearchConceptsErythropoiesis-stimulating agentsChronic kidney diseaseEpoetin alfaDarbepoetin alfaTREAT trialTypes of ESAsNew clinical evidencePrimary care physiciansMedicare AdvantageUptake of evidenceCare physiciansAnemia treatmentClinical evidenceKidney diseasePhysician genderMedicare feeUnsafe treatmentSegmented regression approachStudy periodPhysiciansService populationConsistent changesAlfaHigher useTreatment
2018
Bringing Vioxx back to market
Ross JS, Krumholz HM. Bringing Vioxx back to market. The BMJ 2018, 360: k242. PMID: 29371221, DOI: 10.1136/bmj.k242.Commentaries, Editorials and Letters
2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReview
2014
Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCross-Sectional StudiesEuropean UnionHumansInternational AgenciesLegislation, DrugPharmaceutical PreparationsSafety-Based Drug Withdrawals
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose