2022
Consistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy design
2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICDFactors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research