2024
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency
Kambere M, Vu H, Kappel D, Oh K, Budashewitz P, Concato J. Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic Innovation & Regulatory Science 2024, 58: 987-995. PMID: 38913114, PMCID: PMC11335776, DOI: 10.1007/s43441-024-00674-x.Peer-Reviewed Original ResearchCOVID-19 public health emergencyPublic health emergencyFood and Drug AdministrationTrial participantsHealth emergencyClinical practice guidelinesAnalysis of inquirySafety of trial participantsClinical trialsTrial-related activityPractice guidelinesCOVID-19Industry trade associationsConduction of clinical trialsU.S. Food and Drug AdministrationClinical practiceInterested partiesTrade associationsPartiesMedical productsBackgroundThis reportRelated guidanceParticipantsQualitative methodsDrug Administration
2010
Comparative Effectiveness Research
Concato J, Peduzzi P, Huang G, O'Leary T, Kupersmith J. Comparative Effectiveness Research. Journal Of Investigative Medicine 2010, 58: 764. DOI: 10.2310/jim.0b013e3181e3d2af.Peer-Reviewed Original ResearchComparative effectiveness researchVA electronic medical record systemProton pump inhibitor medicationVeterans AffairsBenefits of clopidogrelOptimal medical therapyAcute coronary syndromeCoronary artery bypassDifferent therapeutic optionsPercutaneous coronary interventionEffectiveness researchElectronic medical record systemPatient-oriented researchVA trialArtery bypassCoronary syndromeCoronary interventionMedical record systemInhibitor medicationMedical therapyTherapeutic optionsClinical trialsObservational studyHealth outcomesStudy designProstate Cancer, Comorbidity, and Participation in Randomized Controlled Trials of Therapy
Chao H, Mayer T, Concato J, Rose M, Uchio E, Kelly K. Prostate Cancer, Comorbidity, and Participation in Randomized Controlled Trials of Therapy. Journal Of Investigative Medicine 2010, 58: 566. DOI: 10.2310/jim.0b013e3181cf9002.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerPhase 3 RCTsProstate cancerClinical settingPhase 3 clinical trialsVeterans Affairs Connecticut Healthcare SystemGeneral oncology practiceAbnormal laboratory valuesPopulation of patientsRandomized Controlled TrialsComplete medical recordsSerious medical conditionProportion of menBackground RandomizedChemotherapy regimensCRPC patientsControlled TrialsMedical recordsClinical trialsOncology practiceInclusion criteriaLaboratory valuesCardiac diseaseMedical conditionsClinical care
2000
Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs
Concato J, Shah N, Horwitz R. Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs. New England Journal Of Medicine 2000, 342: 1887-1892. PMID: 10861325, PMCID: PMC1557642, DOI: 10.1056/nejm200006223422507.Peer-Reviewed Original ResearchConceptsCase-control studyObservational studyBacille Calmette-Guérin (BCG) vaccineCalmette-Guérin vaccineRandomized clinical trialsClinical topicsIndividual observational studiesEffect of vaccinationEffect of treatmentMEDLINE data baseActive tuberculosisControlled TrialsPercent confidence intervalsClinical trialsOdds ratioRelative riskSummary estimatesMajor medical journalsSame interventionTrialsResearch designConfidence intervalsHigh gradeTreatment effectsOriginal report