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 effortsSubjectsWithdrawalRofecoxibYearsIncidenceDoseExposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures
Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures. New England Journal Of Medicine 2009, 361: 849-857. PMID: 19710483, PMCID: PMC3707303, DOI: 10.1056/nejmoa0901249.Peer-Reviewed Original ResearchConceptsCumulative effective dosesCumulative effective doseEffective dosesEffective doseMean cumulative effective doseImaging proceduresLow-dose ionizing radiationPopulation-based ratesMedian effective doseOutpatient settingGeneral populationHigh dosesUtilization dataDosesEnrolleesStudy periodRadiation exposureNuclear imagingDoseAnnual effective dosesMedical imaging proceduresUnited StatesExposureHealth care marketYears